JOB DESCRIPTION SUMMARY

The Staff Regulatory Affairs Specialist – BD Excellence position reports directly to the BD Interventional Segment’s Surgery VP Regulatory Affairs with a dotted line to the Associate Director of BD Excellence for Surgery. This position is responsible for managing, assessing, and executing on regulatory activities for existing drug and medical device products to create savings for the Surgery business.
This role will work closely with regulatory affairs product owners and the cross functional team to assess changes and author submissions to implement change globally. This role is responsible for developing and communicating RA strategies related to BD Excellence for the Surgery Business Unit’s products, including Advanced Repair & Reconstruction and Surgical Solutions product portfolios. Through collaboration and communication with key stakeholders, the Staff Regulatory Affairs Specialist – BD Excellence will successfully negotiate with regulators and ensure significant cost savings to the Surgery business.

JOB DESCRIPTION

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 us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to 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 Staff Regulatory Affairs Specialist – BD Excellence is a strategic thought partner to the Business Unit supporting productivity and will collaborate effectively with cross functional partners to provide regulatory expertise to effectively develop regulatory strategies that successfully lead products through the FDA clearance/approval process, as well as other global regulatory agencies.

SKILLS/KNOWLEDGE

• 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, handling several projects concurrently.
• Effectively copes with change and can comfortably handle and communicate risk and uncertainty.
• 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 and drug testing methods and statistics, as applicable.
• Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in technical area such as biology, chemistry, engineering or medical-related field

PREFERRED QUALIFICATIONS:

• 5 years of experience in the medical device industry, with at least 3 years in a regulatory role.
• Advanced degree (Masters/PhD)
  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. For most roles, we require a minimum of 4 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. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
  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.

• Write drug and medical device regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), PMA supplements, 510(k)s, and Regulatory authority responses.
• Use technical regulatory skills to propose strategies on complex issues.
• Determine deliverables for regulatory submissions and communicate to appropriate functional representatives to ensure timely and accurate submissions per business objectives.
• Work with functional representatives from other areas such as R&D, Manufacturing, and Quality to review and provide input on regulatory strategy and regulatory impact assessment for product changes.
• Support OUS RA team members in order to maintain effective collaboration and to synchronize domestic and international submissions.
• Work with regulatory product owners to determine submission and approval requirements.
• Assess the acceptability of testing and documentation for submission filing.
• Negotiate and interact with regulatory authorities during the review process to ensure submission approval.
• Build positive relationships with regulatory reviewers.
• Monitor impact of changing regulations on submission strategies and update internal partners.
• Monitor and submit applicable reports and responses to regulatory authorities.
• Submit/review change controls to determine the level of change and consequent submission requirements.
• Strategize with and advise internal partners on regulatory issues and requirements.
• Conduct technical meetings with regulatory advisory committees and government agencies.
• Support and lead assigned improvement/productivity activities.