Director, Regulatory Affairs & Quality Assurance
Imbed Biosciences, West Middleton, WI, United States
Position Summary
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.
Key Responsibilities Regulatory Affairs
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.
Quality Assurance
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.
CE Mark / EU MDR Leadership
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.
Leadership & Cross-Functional Collaboration
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.
Operational Excellence
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.
Education & Experience
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)
CE Marking under EU MDR
Experience with biomaterials, wound care, antimicrobial technologies, or combination products strongly preferred.
Technical Expertise
Deep knowledge of:
FDA regulations (21 CFR Parts 210, 211, 820)
EU MDR (2017/745)
ISO 13485 and ISO 14971
Design controls and risk management
Experience interacting with FDA and Notified Bodies.
Strong understanding of clinical and post-market regulatory requirements.
Leadership Competencies
Strategic and hands‑on leader comfortable in a growth‑stage environment.
Strong executive communication and stakeholder management skills.
Originality and creativity in presenting FDA and QSR regulations so that they are interesting and can be understood on all levels.
Ability to enroll others in quality and compliance initiative.
Highly organized with strong project management capabilities.
Preferred Qualifications
RAC (Regulatory Affairs Certification) and/or ASQ certifications (CQE, CQA).
Experience bringing products from development through commercialization in both U.S. and EU markets.
#J-18808-Ljbffr
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.
Key Responsibilities Regulatory Affairs
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.
Quality Assurance
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.
CE Mark / EU MDR Leadership
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.
Leadership & Cross-Functional Collaboration
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.
Operational Excellence
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.
Education & Experience
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)
CE Marking under EU MDR
Experience with biomaterials, wound care, antimicrobial technologies, or combination products strongly preferred.
Technical Expertise
Deep knowledge of:
FDA regulations (21 CFR Parts 210, 211, 820)
EU MDR (2017/745)
ISO 13485 and ISO 14971
Design controls and risk management
Experience interacting with FDA and Notified Bodies.
Strong understanding of clinical and post-market regulatory requirements.
Leadership Competencies
Strategic and hands‑on leader comfortable in a growth‑stage environment.
Strong executive communication and stakeholder management skills.
Originality and creativity in presenting FDA and QSR regulations so that they are interesting and can be understood on all levels.
Ability to enroll others in quality and compliance initiative.
Highly organized with strong project management capabilities.
Preferred Qualifications
RAC (Regulatory Affairs Certification) and/or ASQ certifications (CQE, CQA).
Experience bringing products from development through commercialization in both U.S. and EU markets.
#J-18808-Ljbffr