Regulatory Affairs Specialist

Regulatory Affairs Specialist

Contract- Via Randstad

Duration- 6 months (High probability of extension)

Your role:

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.

Your Responsibilities:

• 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.

Experience & Skills required to perform this job:

• 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.