Regulatory Affairs Specialist

Randstad; Best; On-site; EUR 55,000 - 66,000; Full time

Benefits offered by this job

Holiday Allowance 8%

Pension Plus Scheme

Home Office Setup €750 net allowance

25 vacation days per year

Travel Allowance

Internet Allowance

Relocation Assistance

Job summary

Randstad is seeking a Regulatory Affairs Specialist to bridge regulatory requirements with viable business solutions. You will support global submissions, optimize processes, and collaborate with cross-functional teams to maintain product compliance throughout the lifecycle.

Responsibilities include leading regulatory planning for new products and changes, preparing labeling, and contributing to audits while mentoring junior staff.

Qualifications

• Bachelor’s degree: 2+ years in Regulatory Affairs, Quality Compliance, or Product Development in medical devices.
• Master’s degree: open to entry-level with strong regulatory knowledge.
• Knowledge of US FDA 21 CFR and ISO 13485 required.
• Experience with regulatory workflows for Class II devices (US FDA).

Responsibilities

• Develop and facilitate regulatory submissions for new and existing products (CE Marking and clinical evaluations).
• Own regulatory planning for NPIs and product changes across development to market maintenance.
• Create, review, and validate labeling to align with international standards.
• Collaborate with central and regional teams on registrations, device listings, UDI, and GTIN.
• Lead safety risk assessments and manage incidents in TrackWise with CAPAs.
• Facilitate change management and notify partners of design/software/manufacturing changes.
• Recommend new regulatory SOPs and templates to improve cross-functional efficiency.
• Communicate regulatory standards to I&D via memos, training, and deployment protocols.
• Support internal/external regulatory audits and mentor junior team members.

Skills

Regulatory affairs

Quality compliance

Regulatory workflows

Medical device regulations

US FDA regulations

ISO 13485

Education

Bachelor's or Master’s degree in regulatory/science

Tools

TrackWise

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: Gross full-time monthly salary ranging from €4,900 to €5,950 (based on a full-time work week), depending on education level and relevant professional experience.
• 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.