Director, Regulatory Affairs
Job Description Summary
The Director Regulatory Affairs position reports directly to the BDI Surgery VP Regulatory Affairs. This position is responsible for the development and leadership of the regulatory affairs function in the Advanced Repair and Reconstruction platform. Through recruiting, hiring, supervision, and development of regulatory affairs personnel in support of key product development programs and overall business objectives, the Director assures compliance with applicable regulations for all pre-market and post-market product support activities.
The Director Regulatory Affairs must be a strategic thought partner to the platform lead supporting the growth agenda in key strategic initiatives. S/he must collaborate effectively with R&D, Marketing, Clinical/Medical Affairs, Quality and
other functional areas to provide his/her regulatory expertise to effectively develop regulatory strategies that successfully lead products through the FDA clearance/ approval process, as well as other global regulatory agencies.
- Recruit, manage, develop and mentor regulatory professionals.
- Prepare and manage annual budgets.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Provide regulatory input to product lifecycle planning.
- Working with regulatory associates, determine submission and approval requirements.
- Assist in regulatory due diligence and acquisition transfer activities.
- Through regulatory staff provide strategic input and technical guidance on regulatory requirements to development teams.
- Manage and execute pre-approval compliance activities.
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. Build positive relationships with reviewers.
- Monitor impact of changing regulations on submission strategies and update internal stakeholders.
- Monitor and submit applicable reports and responses to regulatory authorities.
- Maintain annual licenses, registrations, listings and patent information.
- Ensure compliance with product post-marketing approval requirements.
- Review and approve labeling to ensure compliance with regulations and company policy.
- Review and approve advertising and promotional items to ensure regulatory compliance.
- Assess external communications relative to regulations.
- Review publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information.
- Review and approve required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations.
- Provide regulatory input for and appropriate follow-up to inspections and audits.
- Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
- Submit/review change controls to determine the level of change and consequent submission requirements.
- Provide regulatory input for product recalls and recall communications.
- Provide training for stakeholders on current and new regulatory requirements to ensure company-wide compliance.
- Communicate regulatory agency/industry positions to internal stakeholders.
- Strategize with and advise internal stakeholders on regulatory issues and requirements.
- Conduct technical meetings with regulatory advisory committees and government agencies.
- Accompany inspection team(s) as required.
- Support and lead assigned improvement activities.
- Notify, consult or brief legal counsel when appropriate.
- Function as authorized delegate for function head when required.
- Prepare and take leadership in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations.
- Required – Bachelor of Science degree in a technical discipline (e.g., biology, chemistry or engineering)
- Advanced degree (MS,PhD, etc) preferred
- RAPS Regulatory Affairs Certification (RAC) preferred
- Broad knowledge of materials and manufacturing processes, particularly concerning resorbable technologies and HCT/P products.
- Extensive knowledge and experience in designing global regulatory strategies and ensuring timely submission of high quality documents for medical device product registrations. Regulatory strategies may include clinical strategies for products requiring clinical data for regulatory approval or clearance.
- Knowledge of and experience (8-10 years) with regulatory submission for complex US medical devices ( pre-submissions, RFDs, IDEs, 510(k)s, PMAs) with particular focus on PMA submissions.
- Significant experience gaining regulatory approvals for medical devices outside of the United States.
- Experienced in meeting with, making presentations to, and negotiating with regulators.
- Working experience in medical products design and manufacturing quality system principles and practices.
- Ability to work independently with confidence, resolve conflicts, and negotiate with a “win-win” approach.
- A proven track record of recruiting, developing, and retaining a high performance team.
- Past success operating in a large, matrix-managed organization.
- Solid skill in written and oral communications. Positive energy and enthusiasm to work in a multi-task environment.
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Job posted: 2020-11-18