Director of Regulatory Affairs

*** This is an onsite role located in Middleton, WI***

Imbed Biosciences is a growing medical device company developing advanced wound care technologies with commercial products sold in the U.S. and internationally, as well as an exciting pipeline of products in development. As Director of Regulatory Affairs & Quality Assurance, you'll play a critical role in shaping global regulatory strategy, leading quality systems, and helping bring innovative products to patients around the world.

At Imbed Biosciences, culture is built on the core values of Humility, Integrity, Hunger, and Accountability. We're looking for a collaborative leader who is passionate about innovation, committed to quality and compliance, and motivated by the opportunity to make a meaningful impact on patients' lives.

The Director of Regulatory Affairs & Quality Assurance will lead global regulatory strategy and quality systems for Imbed Biosciences’s portfolio of advanced wound care products. This role is critical in advancing products through U.S. FDA pathways while expanding international market access, including achieving and maintaining CE Mark certification under EU MDR. The role will be responsible for creation, implementation and maintenance of the Quality System processes, in compliance FDA 21 CFR, Part 820, Quality System Regulation and ISO 13485.

• Develop and execute global regulatory strategies aligned with company growth objectives.
• Lead preparation and submission of regulatory filings, including:
• FDA submissions (510(k), PMA, IND/IDE as applicable)
• CE Mark submissions under EU MDR (2017/745), including Technical Documentation
• International regulatory submissions (e.g., Health Canada, TGA)
• Serve as primary contact with regulatory authorities, notified bodies, and international agencies.
• Provide regulatory guidance across product lifecycle, including R&D, clinical, labeling, and commercialization.
• Monitor evolving regulatory requirements (FDA, EU MDR) and proactively assess business impact.

• Lead and maintain a scalable Quality Management System compliant with:
• FDA 21 CFR Part 820 (and transition to QMSR)
• ISO 13485:2016
• EU MDR quality system requirements
• MDSAP (as applicable)
• Ensure inspection readiness for FDA and notified body audits.
• Conduct ongoing company-wide training on FDA and ISO requirements
• Oversee:
• CAPA systems
• Complaint handling and vigilance reporting (including MDR reporting in EU)
• Nonconformance and deviation management
• Document control and training systems
• Drive risk management activities in accordance with ISO 14971.
• Establish and maintain supplier quality and qualification programs.
• Lead Notified Body selection, engagement, and audit readiness.
• Oversee development and maintenance of:
• Technical Documentation (Annex II & III)
• Clinical Evaluation Reports (CERs)
• Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
• Ensure compliance with Unique Device Identification (UDI) and EUDAMED requirements.
• Support European market expansion strategy and lifecycle compliance.

• Build and lead a high-performing Regulatory & Quality team.
• Partner with R&D, Clinical, Manufacturing, and Commercial teams to ensure compliant product development and launch.
• Provide strategic input to executive leadership on regulatory pathways, risks, and timelines.
• Support clinical and reimbursement strategies with regulatory insights.

• Define and track KPIs for regulatory submissions, quality metrics, and audit outcomes.
• Lead continuous improvement initiatives to enhance compliance and operational efficiency.
• Scale regulatory and quality systems to support company growth and commercialization.

• Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree preferred).
• 7+ years of experience in Regulatory Affairs and/or Quality Assurance in medical devices, biotech, or wound care.
• 3+ years in a leadership role.
• Proven experience with:
• FDA regulatory submissions (510(k), De Novo, PMA, or combination products)
• Experience with biomaterials, wound care, antimicrobial technologies, or combination…