Regulatory Affairs Specialist — Global Submissions (Remote)

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

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.