Lead Regulatory Affairs Specialist

iO Associates; Berlin; Hybrid; EUR 55.000 - 91.000; Vollzeit

Zusammenfassung

iO Associates in Berlin is seeking a Lead Regulatory Affairs Specialist to own regulatory strategy for innovative Class IIb medical devices, partnering with R&D, Quality, Product Management and international customers to secure global regulatory approvals.

This senior IC role combines hands-on regulatory leadership with cross-functional influence across design controls, clinical evaluation, and post-market activities, offering ownership, visibility, and a path to shaping global market access.

Qualifikationen

• 5-8 years' Regulatory Affairs experience within the medical device industry.
• Strong knowledge of EU MDR, technical documentation, conformity assessment and global product registrations.
• Experience with design control, risk management, clinical evaluation, product change management and regulatory submissions.

Aufgaben

• Lead EU MDR submissions, conformity assessments and international registrations.
• Own and review technical documentation, declarations of conformity and approval-related documentation.
• Support and drive design control, design changes, risk management, clinical evaluation, usability engineering and software documentation.
• Act as the regulatory subject matter expert for areas including biocompatibility, electrical safety, cybersecurity and applicable regulatory standards.
• Assess regulatory impact of product changes and provide guidance throughout the development lifecycle.
• Work directly with notified bodies, regulatory authorities and international customers to support approvals and registrations.
• Support customer, supplier and regulatory audits while contributing to the ongoing development and maintenance of the Quality Management System (QMS).
• Collaborate with Medical Affairs on safety-related complaints and post-market regulatory activities.

Kenntnisse

Regulatory submissions

EU MDR knowledge

Cross-functional collaboration

Regulatory strategy

Jobbeschreibung

Berlin, Germany (Hybrid) | Up to €91,000 + Bonus

Are you an experienced Regulatory Affairs professional looking to take ownership of regulatory strategy while helping bring innovative medical devices to market?

We're recruiting for a Lead Regulatory Affairs Specialist to join a global medical device manufacturer specialising in minimally invasive surgical technologies. This is a senior individual contributor role where you'll work at the heart of new product development, partnering with R&D, Quality, Product Management and international customers to ensure innovative Class IIb medical devices achieve and maintain global regulatory approval.

The Role

Lead Regulatory Affairs Specialist

You'll take ownership of regulatory activities throughout the product lifecycle, ensuring devices meet global regulatory requirements while supporting successful market access. Acting as a key regulatory expert, you'll collaborate with cross‑functionally teams and external stakeholders to influence product development from concept through to commercialisation.

Key Responsibilities

• Lead EU MDR submissions, conformity assessments and international product registrations.
• Own and review technical documentation, declarations of conformity and approval‑related documentation.
• Support and drive design control, design changes, risk management, clinical evaluation, usability engineering and software documentation.
• Act as the regulatory subject matter expert for areas including biocompatibility, electrical safety, cybersecurity and applicable regulatory standards.
• Assess regulatory impact of product changes and provide guidance throughout the development lifecycle.
• Work directly with notified bodies, regulatory authorities and international customers to support approvals and registrations.
• Support customer, supplier and regulatory audits while contributing to the ongoing development and maintenance of the Quality Management System (QMS).
• Collaborate with Medical Affairs on safety‑related complaints and post‑market regulatory activities.

About You

• 5-8 years' Regulatory Affairs experience within the medical device industry.
• Strong knowledge of EU MDR, technical documentation, conformity assessment and global product registrations.
• Experience with design control, risk management, clinical evaluation, product change management and regulatory submissions.
• Comfortable working cross‑functionally with Engineering, R&D, Quality and Product teams.
• A proactive, hands‑on individual who enjoys taking ownership and influencing regulatory strategy.

What's on Offer?

• Up to €91,000 base salary + bonus
• Hybrid working in Berlin
• A senior individual contributor role with genuine ownership and visibility.
• The opportunity to shape the regulatory strategy for innovative minimally invasive medical devices with global impact.
• A collaborative environment where Regulatory Affairs is a key strategic function within product development.