Director of Regulatory Affairs

Director, Regulatory Affairs — ImBed Biosciences Location: Madison, WI (on-site, hybrid, or remote) About ImBed Biosciences ImBed Biosciences is a medical technology company advancing novel biomaterials that help prevent infections and promote healing. We translate cutting‑edge science into practical solutions for patients and clinicians, partnering with healthcare providers to deliver safe, effective products Role Summary ImBed is seeking a Director, Regulatory Affairs, to lead regulatory strategy and submissions across our wound care and biomaterials portfolio. You will own end‑to‑end regulatory planning and execution for U.S. (FDA) and international markets, partnering closely with R&D, Quality, Clinical, and Commercial teams. This hands‑on leader will develop pathways, prepare submissions, manage interactions with health authorities, and maintain compliance throughout the product lifecycle. Key Responsibilities Lead regulatory strategy for new products, line extensions, and changes, including classification, pathway selection (e.g., 510(k), De Novo), and global registration planning. Plan, author, and manage high‑quality regulatory submissions (e.g., 510(k), pre‑subs, technical files, design dossiers, change notifications) and responses to requests for additional information. Serve as primary contact for FDA and other competent authorities; coordinate and lead pre‑submission meetings and regulatory interactions. Provide regulatory input to product development from concept through launch, including design controls, risk management, biocompatibility, sterilization/packaging validation, and labeling claims Partner with Clinical/Medical Affairs to align evidence strategies (clinical, performance, usability) with regulatory requirements. Ensure compliant labeling, promotional and advertising review, and post‑market surveillance in collaboration with Quality and Markeing. Maintain product registrations, listings, and device listings; manage UDI/GUDID and establishment registrations. Monitor, interpret, and communicate relevant regulatory changes and standards; update internal procedures and strategies accordingly. Support internal and external audits/inspections; contribute to CAPA and change control processes. Mentor team members and build scalable RA processes, templates, and best practices. Qualifications Bachelor’s degree in a scientific/engineering discipline (biomedical, chemical, materials, or related). Advanced degree a plus. 6+ years of regulatory affairs experience in medical devices, combination products, or biomaterials; experience with wound care, dressings, or antimicrobial technologies preferred. Demonstrated success leading U.S. FDA submissions (510(k); De Novo a plus) and international registrations (e.g., EU MDR/UKCA/Health Canada). Strong knowledge of applicable regulations and standards (e.g., 21 CFR Parts 807/820/801, ISO 13485, ISO 14971, ISO 10993 series, IEC 62366, sterilization/packaging standards). Experience with QMS interfaces (design control, risk management, change control, CAPA) and cross‑functional development teams. Excellent technical writing, project management, and communication skills; ability to translate science and testing into clear regulatory narratives. Proven ability to lead meetings with regulators and manage timelines under ambiguity. RAC certification and/or prior leadership of pre‑sub interactions preferred. Nice-to-Have Experience with antimicrobial claims, drug‑device combination considerations, or clinical evaluation/reporting. Familiarity with UDI/GUDID, eSTAR, and digital submission tools. Global market experience beyond U.S./EU (e.g., Canada, Australia, LATAM, APAC). Success Metrics (first 12–18 months) On‑time delivery of key submissions (e.g., pre‑sub, 510(k)) with high‑quality dossier content and efficient review cycles. Clear regulatory plans integrated into product roadmaps, with risk/mitigation documented and communicated. Robust labeling and claims governance; compliant promotional review process in place. Up‑to‑date registrations/listings and effective change control support. Work Arrangement This role can be based in Madison, WI or performed hybrid/remote within the U.S. Periodic travel to Madison and/or regulatory meetings may be required. #J-18808-Ljbffr