About Bioretec

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 that eliminate the need for implant removal surgery, reducing patient burden and healthcare costs. After securing De Novo approval for our RemeOs trauma screw 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 organization looking for a clinical affairs leader who shares our commitment to improving patient outcomes through innovation.

The Clinical Affairs Lead provides strategic leadership for the planning, execution, and delivery of clinical research activities across Bioretec’s medical device portfolio.

You will define the global clinical evidence generation strategy, execute clinical studies from design through completion, and generate the clinical evidence and publication strategies required to support regulatory approvals and product adoption. Working closely with Regulatory Affairs, R&D, Quality, and external clinical partners, you will play a critical role in advancing our products to market.

This is a hands-on role that combines strategic leadership with operational execution. You will also lead and mentor Clinical Affairs team members and serve as a key interface with investigators, key opinion leaders (KOLs), and regulatory stakeholders.

Clinical Strategy & Evidence Generation

• Define and implement global clinical evidence generation strategies aligned with product development and regulatory objectives in support of both approvals and in-market adoption
• Lead the generation of clinical evidence demonstrating product safety, performance, and effectiveness, tied to a publication strategy that continues to advance product adoption and category leadership
• Support regulatory submissions with cost-effective, well-documented and high-quality clinical data and related documentation

Clinical Study Management

• Oversee the design, planning, and execution of clinical investigations in accordance with GCP, ISO 14155, EU MDR, and all FDA requirements
• Manage clinical studies end-to-end, including budgeting, timelines, monitoring, and reporting
• Ensure studies are conducted in compliance with protocols, regulatory requirements, and ethical standards

Operational Leadership

• Lead and mentor Clinical Affairs team members
• Establish and improve clinical processes, tools, and documentation standards
• Monitor study progress and ensure delivery against timelines, budget and quality expectations

Stakeholder & Partner Management

• Manage relationships with investigators, clinical sites, CROs, and research partners
• Build and maintain strong networks with KOLs and clinical experts
• Coordinate contracts and oversee external partner performance

Cross-functional Collaboration

• Partner closely with Regulatory Affairs, Quality Assurance, R&D and Commercial/Marketing teams
• Support usability studies, clinical risk management, and post-market surveillance activities
• Contribute to product training, clinical communication, and customer support materials

Compliance & Quality

• Ensure clinical activities align with ISO 13485 quality management systems
• Oversee clinical documentation, including study plans, monitoring plans, eCRFs, and study reports
• Support regulatory and ethics committee submissions as required

Essential

• Master´s degree (or higher) in life sciences, medicine, biomaterial engineering, or a related field
• Significant experience in Clinical Affairs or clinical research within the medical device industry, ideally in orthopedics
• Hands-on experience leading and/or supporting FDA regulatory submissions with clinical data
• Strong knowledge of FDA requirements, EU MDR, RWE and PMCF regulations
• Proven experience managing clinical studies and working with investigators, CROs, and clinical partners
• Exceptional written and spoken English skills required for clinical documentation and regulatory interaction
• Based in the EU with the legal right to work and willingness to travel as required

Highly Desirable

• Experience with orthopedic, implantable, or surgical medical devices
• Familiarity with ISO 14155, GCP, and ISO 13485
• Experience in a scale-up or growth-stage company

Leadership & Collaboration

• Builds strong cross-functional relationships
• Effective communicator across scientific and business audiences
• Able to operate in a fast-paced, evolving environment
• Proactive and solution-oriented mindset

Technical Expertise

• Strong clinical study design and execution expertise
• Deep understanding of clinical regulations (US & EU)
• High-quality clinical documentation and reporting
• Detail-oriented with strong analytical skills

• A key role in advancing innovative medical technologies to global markets
• Opportunity to shape clinical strategy in a growing, mission-driven company
• Close collaboration with leading clinical and academic partners
• Competitive compensation
• Flexible, remote-first working model within the EU
• The opportunity to improve patient outcomes worldwide

Please submit your CV and a brief cover letter (in English) outlining your relevant clinical research experience and 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.