Our start-up client is developing breakthrough medical technologies and and they’re adding a Senior Regulatory Affairs Specialist to help bring these innovations to patients worldwide. The Senior Regulatory Affairs Specialist will be responsible for obtaining CE Mark approval, managing day-to-day submission tasks for device and material changes, and handling study changes across Europe, the US, and Canada. This role requires a "grinder" mentality: someone who can work independently while collaborating with cross-functional teams, particularly design assurance, and who is not afraid to ask questions.

In this role, you’ll own key regulatory activities that drive U.S. and global submissions, ensure compliance, and keep products aligned with evolving FDA and EU MDR requirements. You’ll collaborate closely with engineering and clinical teams, shaping strategy and ensuring documentation is accurate, complete, and compliant.

Your role with the company:

• Lead efforts to secure CE Mark approval, which will be a primary focus for the first year.

• Prepare and submit technical documentation for regulatory approvals.

• Develop and implement post-market regulatory Standard Operating Procedures (SOPs).

• Manage day-to-day submission work for various device changes, material changes, and study changes.

• Ensure compliance with General Safety and Performance Requirements (GSPR) and other relevant standards.

• Demonstrate full or partial compliance with regulatory standards.

• Collaborate closely with the design assurance team on biocompatibility responsibilities, ensuring all necessary paperwork and reports are in order.

• Prepare and submit 30-day supplements for the US and 5-day notifications.

Desired Profile:

• BS Engineering degree preferred

• Experience with post-market regulatory submissions is essential; pre-market regulatory experience is highly desirable.

• Experience with 510(k) devices is acceptable.

• Implantable device experience is a plus, but not required.

• Ability to work independently, manage multiple submissions, and meet deadlines.

• Comfortable engaging with other departments to gather necessary information and ask questions.

• Ideally, some engineering background due to the cross-functional nature of the teams.

• A direct and resilient personality, capable of thriving in a challenging, fast-paced environment.

Join a nimble, mission-driven team where your work directly impacts patient care — and where your regulatory expertise truly matters.