Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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.
Remote or USA RI - Warwick
Primary Work LocationUSA RI - Warwick
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.
Staff Regulatory Affairs Specialist
I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job.
Global Regulatory Operations Labeling Specialist
I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on.
Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist