Principal/Senior Regulatory Affairs

Rigicon is a New York based medical device manufacturer.

Principal/Senior Regulatory Affairs (IC) — MDR & OUS (Non‑US)

Location: Remote within EMEA (occasional travel for NB/audits)

Reports to: Head of Regulatory Affairs

How we work: Outcomes > hours. We measure results, protect maker time, and trust you to manage your schedule.

About the role

We’re hiring a senior, hands‑on individual contributor to own critical MDR work on an assigned portfolio (≈70%) and support non‑US registrations/audits (≈30%). Tight, credible evidence. Calm NB interactions. Clean renewals. Confidential product details are shared during interviews.

What you’ll own (≈70%) — MDD ➜ MDR (assigned products)

• Lead gap assessments and refresh Annex II/III technical documentation.
• Plan/author CER & PMCF (Annex XIV) and align with Clinical/Medical.
• Keep PMS/PSUR on cadence; update ISO 14971 risk files and change control.
• Maintain labeling/claims rationale (intended use/indications, IFU, symbols).
• Prepare and maintain UDI/EUDAMED data for assigned SKUs.
• Manage day‑to‑day Notified Body interactions (pre‑subs, Q&A, clean, traceable responses).

What you’ll support (≈30%) — OUS registrations & audits (Non‑FDA)

• Maintain/renew registrations across priority markets (e.g., Canada, Australia, Japan, Brazil, UK, Switzerland, Korea MFDS/KFDA).
• Leverage MDSAP for efficient QMS audit coverage; keep RA deliverables inspection‑ready.
• Participate in Notified Body, MDSAP, customer, and supplier audits; draft precise responses and drive CAPA closure.

Scope note: You’ll collaborate with colleagues on US topics when helpful, but you won’t own FDA submissions.

What you’ll bring

• 8–12+ years in Medical Device Regulatory Affairs (this is not a junior role).
• Proven MDD/MDR track record (Class IIa/IIb/III preferred) and direct Notified Body engagement.
• Strong CER/PMCF, PSUR, PMS/Vigilance writing and argumentation.
• Working fluency with UDI/EUDAMED and disciplined data management.
• Practical OUS experience in several of: Health Canada, TGA (AU), PMDA (JP), ANVISA (BR), UKCA, MedDO (CH), MFDS/KFDA (KR); familiarity with MDSAP.
• Calm, precise communicator; collaborative with Quality, Clinical, R&D, and Commercial.
• Excellent written English; another European language is a plus.

How we help you grow

• Ownership & scope: take on increasingly complex MDR files and NB interactions.
• Choice of depth: become our internal go‑to for CER/PMCF or UDI/EUDAMED.
• Breadth: expand country portfolios; mentor associates; optional path to people leadership later.
• Focus time: protected deep‑work blocks; short written updates instead of endless meetings.
• Enablement: modern eQMS/RIM, access to specialist partners when they’re the right lever.

What success looks like

• Results over hours spent