Global Regulatory Affairs Specialist - Remote & Benefits

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

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.