Bioretec is a Finnish medical device company pioneering bioresorbable fixation implants for orthopedic surgery across global markets. Our material science platforms translate into category-leading absorbable implant technologies which eliminate the need for implant removal surgery, reducing patient burden and healthcare costs. After securing De Novo approval for our RemeOs platform in 2023, the company has ambitions to progress its breakthrough product pipeline in both the US and global markets.

We are a science-led, mission-driven organisation and we are looking for an experienced US regulatory affairs professional who shares our commitment to improving patient outcomes through innovation.

Bioretec is entering an exciting phase of growth as we expand our presence in the United States and advance our portfolio of innovative bioresorbable orthopedic implants. We are seeking an experienced regulatory professional to lead our US regulatory strategy and execution, ensuring successful navigation of the FDA regulatory landscape and supporting the company's long-term commercial ambitions.

Reporting directly to the CEO, you will serve as Bioretec's subject matter expert for US regulatory affairs and act as the primary interface with the FDA. You will play a critical role in shaping regulatory pathways for both current and future products, providing strategic guidance across development, clinical, quality and commercial activities.

Working closely with cross-functional teams and external regulatory partners, you will drive regulatory activities from product development through market authorization and lifecycle management. You will represent the regulatory perspective in key business decisions, helping to balance innovation, risk and speed to market.

This is a hands-on senior role that combines strategic thinking with operational execution. The successful candidate will be equally comfortable defining regulatory strategy, leading FDA interactions and contributing directly to submission preparation and review.

US Regulatory Strategy & FDA Submissions

• Define and execute the US market access strategy for Bioretec’s bioresorbable implant portfolio
• Lead the preparation, submission, and management of FDA regulatory filings, including:
  • 510(k) Premarket Notifications
  • IDE (Investigational Device Exemption) applications for clinical studies
  • De Novo classification requests as applicable
• Serve as primary FDA correspondent; manage all agency interactions, meetings (Q-Sub, Pre-Sub), and responses to deficiencies
• Maintain current knowledge of FDA guidance documents, QSR/21 CFR Part 820, and evolving QMSR requirements
• Advise on US clinical study design to meet FDA evidentiary standards

Global Regulatory Collaboration

• Collaborate with EU regulatory colleagues to align US and global regulatory strategies
• Provide US regulatory input to global development programs
• Support regulatory assessments for future market expansion opportunities
• Contribute to regulatory due diligence for partnerships and licensing opportunities

Strategic Leadership & Cross-Functional Collaboration

• Establish regulatory processes, SOPs, and a submissions management system
• Partner with R&D, Clinical, Manufacturing, and Legal from early design through post-market surveillance
• Contribute to internal regulatory reviews and strategic risk assessments

Quality & Compliance

• Ensure regulatory strategy is aligned with and supports the company’s ISO 13485 QMS
• Support regulatory aspects of PMS, PMCF, and vigilance reporting
• Provide regulatory expertise in due diligence activities for potential partnerships, licensing agreements, or M&A activity

Essential

• 10+ years of medical device regulatory affairs experience, with at least 4 years focused on FDA submissions
• Demonstrated track record of successful 510(k) clearances and/or PMA approvals as submission lead
• Familiarity with EU MDR 2017/745 and ability to collaborate effectively in a global regulatory environment
• Near-native English speaker — required for FDA correspondence, technical writing, and agency meetings
• Based in the EU or UK, with eligibility to travel to the US as required

Highly Desirable

• Experience with orthopaedic implants, biomaterials, or bioresorbable/absorbable devices
• Hands-on experience with US clinical study conduct
• RAC (Regulatory Affairs Certification) from RAPS

Strategic Influence & Collaboration

• Credible regulatory ambassador with agencies
• Persuasive communicator — board to bench
• Builds high-trust cross-functional relationships
• Comfortable in ambiguity; entrepreneurial mindset

Technical Expertise

• Exceptional technical writing in English
• Deep FDA regulatory science knowledge
• Systematic, detail-oriented submission management
• Strategic risk thinking across global markets

• A leadership role with genuine strategic influence at a pivotal growth stage
• Opportunity to shape US regulatory strategy for a breakthrough orthopedic technology platform
• Collaboration with leading US and EU academic and clinical partners
• Compensation package including eligibility for equity participation
• Flexible, remote-first working model within the EU or UK
• A mission you can be proud of — improving surgical outcomes for patients globally

Please submit your CV and a brief cover letter (in English) outlining your most relevant regulatory submission experience and your motivation for joining Bioretec. Application deadline: 30 July, 2026. Applications will be reviewed on an ongoing basis. For further information about the role, please contact Sarah van Hellenberg Hubar-Fisher, sarah.hubar-fisher@bioretec.com.

Bioretec is an equal opportunity employer committed to creating an inclusive and diverse workplace. We welcome applications from all qualified candidates regardless of gender, age, ethnicity, religion, disability, sexual orientation, or background.