Your search query
REGULATORY AFFAIRS OFFICER – MDR & TECHNICAL DOCUMENTATION
WHAT YOU WANT TO KNOW
- Location: Soesterberg, Netherlands
- Salary: €50,000 - €65,000, including holiday allowances based on x12.96 payment
- Hybrid: 3 days onsite – 2 days at home
- Department: Regulatory Affairs
- Level: Intermediate
- Permanent opportunity
- Fluent English required
- Dutch preferred but not essential
ROLE DETAILS
Join a global organisation specialising in advanced dental and medical device materials, supporting regulatory activities across a highly regulated international environment.
This role will focus primarily on EU MDR compliance, Technical Documentation and product lifecycle activities. You will work across Technical Files, labelling, UDI, EUDAMED and regulatory change assessments, while collaborating closely with R&D, Quality, Manufacturing and Clinical teams.
The position offers the opportunity to take ownership of regulatory projects and, over time, develop into broader global Regulatory Affairs activities including regulatory strategy, new product introductions and international expansion.
KEY RESPONSIBILITIES
- Prepare, remediate and maintain Technical Documentation in accordance with EU MDR 2017/745 throughout the product lifecycle
- Coordinate Technical Documentation inputs from R&D, Quality, Manufacturing, Clinical and other subject matter experts
- Support UDI assignment, UDI lifecycle management and EUDAMED data submissions
- Review regulatory compliance relating to product changes, design modifications, labelling and documentation updates
- Support labelling and IFU compliance and assess the regulatory impact of associated changes
- Perform regulatory impact assessments relating to MDR transition and post-market compliance activities
- Monitor relevant regulatory developments, identify potential risks and provide practical regulatory guidance to internal teams
- Independently manage regulatory projects, track actions and coordinate cross-functional activities through to completion
ESSENTIAL EXPERIENCE
- Minimum 3 years' Regulatory Affairs experience within medical devices, dental devices, pharmaceuticals, biotechnology or another regulated industry
- Experience preparing, maintaining or remediating regulatory Technical Documentation
- Working knowledge of medical device regulations and quality systems
- Experience supporting regulatory compliance and product lifecycle activities
- Strong analytical skills with excellent attention to detail
- Ability to independently manage regulatory activities while working across multiple functions
- Fluent written and spoken English
QUALIFICATIONS
- Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Chemistry, Materials Science, Regulatory Affairs or a related scientific discipline
- Knowledge of EU MDR 2017/745 is strongly preferred
- Experience with Technical Files, EUDAMED, UDI, labelling or IFU compliance is highly desirable
- Dutch language skills are beneficial but not essential
REGULATORY AFFAIRS OFFICER – INTERNATIONAL REGISTRATIONS & MARKET ACCESS
WHAT YOU WANT TO KNOW
- Location: Soesterberg, Netherlands
- Salary: €50,000 - €65,000, including holiday allowances based on x12.96 payment
- Hybrid: 3 days onsite – 2 days from home
- Department: Regulatory Affairs
- Level: Intermediate
- Permanent opportunity
- Fluent English required
- Dutch preferred but not essential
ROLE DETAILS
Join a global organisation specialising in advanced dental and medical device materials, supporting regulatory activities across multiple international markets.
This role will focus primarily on international registrations, regulatory submissions and global market access. You will work across registration dossiers, new product registrations, renewals, change notifications and ongoing registration maintenance.
The position will involve close collaboration with internal teams, distributors, regulatory representatives, consultants and authorities worldwide. Over time, there will also be the opportunity to develop into broader global Regulatory Affairs activities including regulatory strategy, Asia-Pacific Regulatory Affairs, new product introductions and international market expansion.
KEY RESPONSIBILITIES
- Prepare, compile and maintain regulatory registration dossiers for international markets
- Support new product registrations, renewals, change notifications and ongoing registration maintenance
- Coordinate regulatory submissions and ensure required documentation is prepared and maintained
- Track registration activities and provide clear progress updates to internal stakeholders
- Work with distributors, regulatory representatives, consultants and regulatory authorities across international markets
- Support EUDAMED activities and assess the impact of product, labelling and documentation changes on regulatory registrations
- Monitor global regulatory developments and assess potential impacts on products, registrations and market access
- Independently manage regulatory projects across multiple markets, identifying risks and driving actions through to completion
ESSENTIAL EXPERIENCE
- Minimum 3 years' Regulatory Affairs experience within medical devices, dental devices, pharmaceuticals, biotechnology or another regulated industry
- Experience preparing regulatory submissions and/or international registration dossiers
- Experience supporting international product registrations and market access activities
- Working knowledge of medical device regulations and quality systems
- Experience coordinating regulatory activities across internal teams and external stakeholders
- Strong organisational skills with the ability to manage multiple registrations, projects and priorities
- Fluent written and spoken English
QUALIFICATIONS
- Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Chemistry, Materials Science, Regulatory Affairs or a related scientific discipline
- Experience with international regulatory frameworks such as FDA, Health Canada, TGA, PMDA, NMPA or ANVISA is highly desirable
- Knowledge of EU MDR 2017/745, EUDAMED and UDI requirements is beneficial
- Dutch language skills are beneficial but not essential
SENIOR TECHNICAL PROJECT MANAGER
WHAT YOU WANT TO KNOW
- Location: Chicago, IL
- Salary: $110,000 – $160,000
- Travel: Up to 30%, including international travel
- Own complex technology projects from initial concept and technical scoping through to global deployment and long-term support.
- Initial projects will include large-scale, multi-phase LED video wall programmes for a major retail brand.
- A highly client-facing role combining technical leadership, project management and hands-on technology across hardware, software and physical display systems.
ROLE DETAILS
The Senior Technical Project Manager will take ownership of complex, high-visibility technology programmes from initial scoping and architecture through development, installation and global deployment.
You'll act as the central technical point between clients, engineering, design, production, sourcing, vendors and installation teams, ensuring projects are technically feasible and delivered successfully across scope, timeline, budget and quality.
This isn't a purely process-driven Project Manager position. You'll need the technical curiosity and hands-on ability to understand the technology being deployed, challenge solutions, evaluate prototypes and help resolve complex technical problems.
KEY RESPONSIBILITIES
- Own multiple complex technology programmes from initial technical scoping and architecture through development, installation and deployment.
- Act as the primary technical contact for clients, translating requirements into practical technical solutions and project plans.
- Lead the integration of hardware, software and physical display technologies within large-scale retail environments.
- Define technical requirements, BOMs, resource requirements and support sourcing, procurement and estimation.
- Manage project roadmaps, budgets, risks, milestones and multiple parallel workstreams involving internal and external stakeholders.
- Evaluate, test and validate technology solutions through prototyping, demonstrations and pre-deployment testing.
- Work closely with technology vendors and manufacturing partners to develop and deliver project-specific solutions.
- Maintain technical documentation including wiring schematics, integration maps, BOMs, QA processes and installation standards.
- Act as a senior escalation point for complex technical issues, supporting troubleshooting and root-cause resolution.
ESSENTIAL EXPERIENCE
- 5+ years' experience within technical project management across retail technology, experiential technology, systems integration, hardware/software or similar environments.
- Proven experience delivering large, technically complex projects involving multiple stakeholders, suppliers and workstreams.
- Strong understanding of both hardware and software systems, with the ability to confidently engage in detailed technical discussions.
- Experience with LED systems, digital signage or retail technology would be highly advantageous.
- Familiarity with technical documentation including wiring schematics, integration maps and technology BOMs.
- Strong hands-on technical aptitude and a genuine interest in understanding, testing and troubleshooting technology.
- Experience working directly with clients and presenting technical information to both technical and non-technical stakeholders.
- Strong project leadership skills with experience managing scope, timelines, budgets, risks and competing priorities.
QUALIFICATIONS
- Bachelor's degree in Engineering, Computer Science, Information Technology or a related technical discipline preferred; equivalent relevant experience will also be considered.
- Ability to travel up to 30% domestically and internationally, including travel to China.
- Flexibility to work across international time zones, including regular communication with teams in China.
TECHNICAL SOLUTIONS MANAGER
WHAT YOU WANT TO KNOW
- Location: Chicago, IL
- Salary: $110,000 – $130,000
- Lead and develop a team of Technical Support Engineers responsible for Level 2 support across deployed digital technology.
- Take ownership of complex technical escalations involving hardware, software, networking, digital displays, media players and connected devices.
- Combine hands-on technical problem solving with team leadership, rather than moving away from the technology.
- Work across client support, installation, engineering, technology teams, vendors and OEMs supporting large-scale digital environments.
ROLE DETAILS
The Technical Solutions Manager will lead the Level 2 Technical Solutions function, taking responsibility for both the performance of the support operation and the development of the Technical Support Engineering team.
You'll oversee technical support for deployed digital environments, covering proactive monitoring, remote diagnostics, troubleshooting and escalation management. You'll also remain involved in complex technical issues yourself, helping the team resolve problems across integrated hardware, software and connectivity.
A key part of the position will be building a scalable support operation that improves resolution times, system uptime and the overall client experience.
KEY RESPONSIBILITIES
- Lead, coach and develop a team of Technical Support Engineers, managing workload, priorities, technical capability and performance.
- Oversee daily Level 2 support operations including monitoring alerts, ticket queues, escalations, ageing incidents and client commitments.
- Lead complex remote troubleshooting across hardware, software, firmware, networks, media players, displays, sensors, interactive devices and connected peripherals.
- Act as the management escalation point for complex, recurring or high-impact technical incidents, coordinating Level 3, field, vendor and OEM support where required.
- Drive root-cause analysis and corrective actions to reduce recurring technical failures and improve system reliability.
- Develop scalable support processes, troubleshooting guides, technical documentation, SOPs and escalation pathways.
- Work with Installation Services to ensure effective technical handover, commissioning and long-term support of deployed systems.
- Define and monitor service KPIs, identifying trends and opportunities to improve resolution speed, support quality and system uptime.
ESSENTIAL EXPERIENCE
- 5+ years' experience within deployed technology, digital signage, AV systems, retail technology, IT operations, field technology or a comparable technical support environment.
- 2+ years' experience leading or managing technical teams, including coaching, workload prioritisation and performance management.
- Strong hands-on troubleshooting experience across integrated hardware, software, networking and connected devices.
- Working knowledge of TCP/IP networking, Wi-Fi and wired connectivity, HDMI/DisplayPort signal paths, device configuration and remote-access tools.
- Experience working with displays, media players, sensors, peripherals, firmware and content-delivery systems.
- Experience managing incidents, escalations and service levels through platforms such as Salesforce Service Cloud, ServiceNow, Zendesk or similar.
- Experience developing technical documentation, troubleshooting processes, SOPs and root-cause/corrective-action reporting.
- Strong client-facing communication skills with the ability to translate technical issues into clear business impact, ownership and next steps.
- Experience supporting multi-site retail deployments, digital signage platforms, third-party field-service providers or warranty/RMA processes would be particularly valuable.
QUALIFICATIONS
- Bachelor's degree in Information Technology, Computer Science, Engineering, Electronics or a related technical discipline preferred; equivalent relevant experience will also be considered.
- Ability to support occasional after-hours technical escalations.
- Flexibility to travel to client sites, company facilities or partner locations when required.
TECHNICAL TRAINER – METAL ADDITIVE MANUFACTURING
WHAT YOU WANT TO KNOW
- Salary: €4,000–€4,300 per month + 4% annual bonus
- Permanent position
- Location: Leuven, Belgium
- Hybrid working: 1–2 days working from home, depending on the training schedule
- Travel: Approximately 15–25% international travel
- Benefits: Company car, charge card, mobile phone, pension, hospitalisation insurance and meal vouchers
- Join a specialist team delivering technical training on cutting-edge industrial metal Additive Manufacturing systems
ROLE DETAILS
Whether you're already delivering technical training or you're a hands-on Field Service Engineer looking to transition into technical training, this is an excellent opportunity to join a global leader in industrial metal Additive Manufacturing.
You'll primarily be responsible for delivering engaging classroom and hands-on training to customers, distribution partners and internal technical teams. Most of your time will be spent delivering training, with the opportunity to support the ongoing development of training materials alongside the existing team.
Full on-the-job training will be provided, making this an ideal opportunity for someone with around 2–3 years' experience working with complex industrial machinery who enjoys sharing technical knowledge and helping others develop.
Working closely with Engineering and R&D, you'll ensure training content remains aligned with the latest product developments while supporting customers operating within highly regulated industries including aerospace, medical, defence and advanced manufacturing.
ROLE RESPONSIBILITIES
- Deliver classroom and hands-on technical training for customers, distribution partners and internal technical teams.
- Demonstrate machine operation, maintenance and safe working practices during practical training sessions.
- Monitor practical training exercises and support trainees throughout the learning process.
- Assess trainee understanding through practical exercises, written assessments and certification activities.
- Support the continuous improvement of training materials, presentations and technical documentation.
- Work closely with Engineering and R&D to ensure training content reflects the latest product developments.
- Support the development of digital learning content and Learning Management System (LMS) resources where required.
ESSENTIAL EXPERIENCE
- Approximately 2–3 years' experience working with industrial machinery or other complex capital equipment.
- Experience as a Field Service Engineer or in a similar hands-on technical engineering role.
- Strong mechanical and electrical technical knowledge.
- Ability to understand complex technical concepts and communicate them clearly.
- Excellent communication and presentation skills.
- Fluent English communication skills.
- Willingness to travel internationally (approximately 15–25%).
DESIRABLE EXPERIENCE
- Experience within industrial metal Additive Manufacturing.
- Knowledge of electronics, vacuum systems, pneumatics, lasers or industrial machinery.
- Experience using Learning Management Systems (LMS), virtual classroom platforms or digital training tools.
- Video editing experience using Adobe Premiere Pro or After Effects.
- Dutch or French language skills.
- Bachelor's or Master's degree in an Engineering or Technical discipline.
About the Company
We are currently recruiting for a Digicon Finishing Operator to join a well-established label manufacturing business. This role is ideal for somebody with experience operating label finishing, converting, or print production machinery within a manufacturing environment.
About the Role
You will be responsible for operating and maintaining Digicon label finishing equipment, converting digitally printed label rolls into finished products. The position involves setting up finishing processes, ensuring quality standards are maintained, monitoring production output, and working efficiently to production schedules within a fast-paced manufacturing environment.
Responsibilities
Operate and set up Digicon finishing machinery
Prepare printed label rolls for finishing operations
Install and align rotary dies, varnish units and finishing tooling
Adjust machine settings to ensure accurate registration, tension and cutting quality
Monitor production runs to maintain quality and consistency
Inspect finished labels and identify any defects or quality issues
Carry out routine machine maintenance, cleaning and basic troubleshooting
Maintain production records and job documentation
Work to production schedules and customer deadlines
Follow all health and safety procedures within the manufacturing environment
Qualifications
Print production, label converting or manufacturing-related training advantageous
Experience operating finishing or converting machinery preferred
Health & Safety awareness preferred
Required Skills
Experience operating label finishing, converting or print production equipment
Knowledge of die-cutting, laminating, foiling, varnishing and slitting processes
Ability to read and interpret job specifications and production documentation
Strong attention to detail and commitment to quality control
Mechanical aptitude and problem-solving ability
Ability to work efficiently within deadline-driven production environments
Good communication and teamwork skills
Understanding of manufacturing health and safety procedures
Pay Range and Compensation Package
Salary: £29,000 – £32,000 per annum, depending on experience.
Benefits
Company pension
Cycle to Work scheme
Life insurance
Free on-site parking
Working Hours
Rotating Double Day Shift Pattern (Monday–Friday)
Week 1: 05:50 – 13:25
Week 2: 13:25 – 21:00
Friday shifts are shortened:
Morning Shift: 06:00 – 12:00
Afternoon Shift: 12:00 – 18:00
Flexographic Printer – Job Description 10.03
Flexographic Printer – Job Descrip6on
Role Overview As a Flexographic Printer, you will operate and maintain flexographic prin:ng press (BOBST M4, Mark Andy) to produce high-quality printed materials on substrates such as self- adhesive paper and film. The role involves seKng up prin:ng plates, mixing inks, and monitoring print quality while ensuring produc:on targets are met safely and efficiently.
Key Responsibili6es • Set up and operate 8 colour flexographic prin:ng press (BOBST M4, Mark Andy). • Mount prin:ng plates and cylinders correctly. • Prepare and mix inks to required colour specifica:ons. • Adjust machine seKngs (speed, pressure, alignment) to ensure print quality. • Monitor print runs for colour accuracy, registra:on, and consistency. • Inspect printed materials for defects and maintain quality standards. • Perform rou:ne machine maintenance and cleaning. • Troubleshoot mechanical or prin:ng issues during produc:on. • Maintain produc:on records and job documenta:on. • Follow health and safety regula:ons and company procedures.
Skills and Experience • Experience opera:ng flexographic prin:ng presses. • Knowledge of prin:ng processes, substrates, and inks. • Ability to read job sheets and technical specifica:ons. • Strong aRen:on to detail and quality control. • Mechanical ap:tude and problem-solving skills. • Ability to work under produc:on deadlines. • Teamwork and communica:on skills.
Working Hours / ShiE PaFern: This role operates on a two-shiS rota:on from Monday to Friday:
• Morning ShiS: 05:50 – 13:25 • ASernoon ShiS: 13:25 – 21:00
On Fridays, shorter shiSs apply: • Morning ShiS: 06:00 – 12:00 • ASernoon ShiS: 12:00 – 18:00
Salary Salary: from £35,000 per annum, depending on experience.
Benefits: • Company pension • Cycle to work scheme • Free parking • Life insurance • On-site parking