Regulatory Affairs Specialist

Randstad - Netherlands; Best; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Salary: Best in the market

Holiday Allowance 8%

Pension Plus Scheme

Home Office €750 net allowance

25 vacation days per year

Travel allowance

Internet allowance

Relocation assistance

Job summary

Randstad Netherlands is seeking a Regulatory Affairs Specialist to bridge regulatory requirements and viable business solutions for medical device projects. You will support global submissions and optimize internal regulatory processes throughout the lifecycle.

You will own regulatory planning for new product introductions and changes, collaborate with cross-functional teams on labeling and registrations, and mentor junior staff in a dynamic, international environment.

Qualifications

• Must have regulatory knowledge for medical devices (class II).
• Experience with US FDA 21 CFR and ISO 13485 beneficial.
• Experience managing regulatory workflows for pre/post-market requirements.

Responsibilities

• Develop and facilitate regulatory submissions for new and existing products (CE Marking, clinical evaluations).
• Own regulatory planning for new product introductions and changes.
• Create, review and validate labeling to align with international standards.
• Collaborate with central and regional teams on registrations, listings, UDI and GTIN.
• Lead safety risk assessments and manage incidents in Trackwise.
• Support change management and notify partners of design/software/manufacturing changes.
• Recommend regulatory SOPs and templates to improve efficiency.
• Communicate standards to I&D teams via memos and training.

Skills

Regulatory affairs

Quality compliance

Product development

Education

Bachelor’s degree

Master’s degree

Tools

TrackWise

Regulatory submission software

Job description

As a Regulatory Affairs Specialist, you will bridge the gap between regulatory requirements and viable business solutions for moderately complex projects. Operating under general supervision, you will collaborate with cross-functional teams to maintain product compliance throughout the lifecycle, support global submissions, and continuously optimize internal regulatory processes.

• Develop and facilitate regulatory submissions for new and existing products (including CE Marking and clinical evaluations); prepare technical justifications for submission filing decisions.
• Own regulatory planning for new product introductions (NPI) and product changes, ensuring total compliance from development through market maintenance.
• Create, review, and validate marketing and product labeling materials to ensure alignment with international standards.
• Collaborates with central and regional teams on establishment registrations, device listings, UDI (Unique Device Identification), and GTIN activities.
• Lead safety risk assessments to identify potential compliance issues; manage and track incidents within Trackwise to ensure effective corrective actions.
• Facilitate change management activities, including hosting alignment meetings and notifying global geographic partners of design, software, labeling, or manufacturing changes.
• Recommend system and process enhancements, creating or revising Regulatory SOPs and templates to improve cross-functional efficiency.
• Communicate regulatory standards to the Innovation & Development (I&D) teams through compliance memos, training sessions, and deployment protocols (PDLM/MLD).
• Support internal/external regulatory audits and inspections as required, while serving as an informal resource to mentor junior team members.

Functie-eisen

• With a Bachelor’s Degree: Minimum of 2 years of experience in Regulatory Affairs, Quality Compliance, or Product Development within the medical device industry.
• With a Master’s Degree: Open to entry-level candidates with a strong foundational knowledge of medical device regulations.
• Demonstrated knowledge of US FDA regulations, 21 CFR requirements, and ISO 13485 medical device quality management systems.
• Experience with managing regulatory workflows and pre/post-market requirements for Class II (US FDA) medical devices.

Arbeidsvoorwaarden

• Salary: Best in the market.
• Holiday Allowance – 8% of your annual salary, ensuring you can fully enjoy your time off.
• Pension Plus Scheme – Secure your future with our comprehensive retirement plan.
• Home Office Setup – Receive a €750 net allowance to create a comfortable and productive workspace.
• Time to Recharge – Enjoy 25 vacation days per year (based on a 40-hour workweek).
• Travel Allowance – Support for commuting expenses.
• Internet Allowance – Contribute to seamless remote work.
• Relocation Assistance – Moving to the Netherlands? We’ve got you covered.