Job Requisition NameSenior Director, Regulatory Affairs
Job Requisition NoVN8493
Work Location NameUSA - Remote
Worker BasisFull Time
Worker TypeEmployee
Contract TypePermanent
Applications Close DateFeb 28, 2027
PurposeThe
Senior Director, Regulatory Affairs provides strategic direction and leadership to regulatory teams responsible for the development, approval, and maintenance of global registrations and market authorizations. Through strong cross-functional partnerships, this role drives the execution of regulatory strategies, initiatives, and projects that enable business growth and support corporate objectives.
Key Responsibilities- Provide strategic regulatory leadership and expertise to cross-functional stakeholders, supporting key business initiatives and driving successful regulatory and organizational outcomes.
- Lead regulatory affairs teams and oversee the development, submission, and maintenance of global regulatory filings, including product registrations, supplements, amendments, progress reports, and periodic regulatory reports. Collaborate effectively with international distributors, regulatory agents, and external consultants as needed.
- Monitor and assess evolving regulatory requirements, guidance, and industry trends, proactively identifying and implementing necessary changes to internal policies, procedures, and compliance practices.
- Resolve complex regulatory issues by providing timely, risk-based recommendations and independently driving execution of solutions.
- Guide teams in developing global regulatory strategies and lead interactions with regulatory authorities to negotiate evidence requirements and facilitate product approvals.
- Ensure the timely approval and ongoing compliance of products throughout their lifecycle, minimizing regulatory risks and supporting business objectives.
- Provide strategic regulatory input to Marketing, Commercial, and Product Development teams regarding product claims, labeling, and promotional materials, ensuring compliance with applicable laws, regulations, and company policies.
- Build and maintain strong, collaborative relationships with key internal stakeholders, regulatory agencies, industry partners, and external experts.
- Demonstrate sound judgment, accountability, and a high level of professional competence while effectively managing multiple priorities in a dynamic environment.
- Serve as a role model and people leader by fostering a culture of integrity, accountability, collaboration, and continuous improvement while exemplifying BVI's core values.
QualificationSkills and Knowledge:- Comprehensive knowledge of global medical device regulations, regulatory frameworks, and compliance requirements (e.g., FDA, EU MDR, Health Canada, PMDA, TGA, ANVISA, and other international regulatory authorities).
- Strong understanding of medical device technologies, product development processes, and lifecycle management principles.
- Broad medical and scientific knowledge, including disease states, clinical practice, and evolving healthcare landscapes.
Minimum Qualifications:- Bachelor of Science degree with 15+ years of relevant regulatory affairs experience; or
- Master of Science (MS) or Master of Business Administration (MBA) with 10+ years of relevant regulatory affairs experience; or
- Doctor of Philosophy (PhD) with 8+ years of relevant regulatory affairs experience.
Preferred Qualifications:- 8+ years of progressive people leadership experience, including leading and developing high-performing regulatory affairs teams.
- Demonstrated success in developing and executing global regulatory strategies for medical devices.
- Proven ability to influence cross-functional stakeholders and drive strategic business objectives.
- Experience interacting with global regulatory authorities and negotiating regulatory pathways and evidence requirements.
- Strong track record of regulatory submissions, approvals, and lifecycle management across multiple international markets.
