Director Regulatory Affairs
: Job Details :

Director Regulatory Affairs

The Director Regulatory Affairs (RA) Position reports directly to the BD Interventional Segment's Surgery VP Regulatory Affairs. This position is responsible for the development and leadership of the regulatory affairs function in the Surgical Solutions platform. In addition to the platform leadership role, the Director will be responsible for developing and communicating RA Strategies related to the Surgery Business Unit's innovation pipeline in emerging areas of interest including hemostats, sealants, and infection prevention products. Finally, the role will collaborate with Surgery RA Platform leads, with the Surgery Strategic Development and Innovation teams and across BD's Interventional Segment RA groups to aid in RA Strategy development. 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.

We are the makers of possible!

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

The Director Regulatory Affairs must be a strategic thought partner to the platform and Business Unit 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.

Responsibilities:

• Recruit, manage, develop and mentor regulatory professionals.
• 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 and 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 and appropriate standards organizations.

Qualifications:

• Bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of ten years of experience. Advance degree preferred.
• Preferred minimum of 10-15 years of experience in the medical device industry, with at least ten years in a regulatory role.
• Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices.
• Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results.
• Experienced in continuous improvement projects, project management, product development processes, and design control.
• Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.
• Effectively copes with change and can comfortably handle and communicate risk and uncertainty.
• Prior management experience.
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
• Ability to be effective in complex projects with ambiguity and/or rapid change.
• Demonstrated self-starter, and highly motivated.
• Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators.
• Ability to interpret medical device testing methods and statistics, as applicable.
• Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization.
• Experience with Clinical Trial applications (US IDE).

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. We require a minimum of four days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable and learn and improve every day. You will work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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