Staff Specialist, Regulatory Affairs

Regulatory Affairs Specialist

This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. This position participates on cross-functional teams, leads the development of global regulatory strategies, authors regulatory submissions, leads interactions with regulatory agencies / notified bodies, reviews design control documents and product labeling, and evaluates proposed device changes. This position interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.

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.

Job Responsibilities :

• Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met
• Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market
• Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements
• Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval
• Leads interactions with FDA, EU notified bodies, and other regulatory agencies on submissions and other issues
• Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications
• Communicates changes to global regions and supports preparation of global notifications as needed
• Understands fundamental global regulatory requirements and different regulatory pathways
• Stays informed of new regulations and changes to existing regulations and communicates to project teams
• Identifies and communicates appropriately quantified risks and mitigation strategies associated with regulatory changes to partners
• Maintains regulatory databases and systems
• Supports regulatory body audits, CAPAs, and other compliance activities
• Reviews advertising and promotional material
• Participates in claims development strategy
• Leads training related to areas of expertise
• Mentors other regulatory colleagues

Minimum Requirements :

Preferred Qualifications :

This position is in an office environment and may require the incumbent to sit, stand and perform general office functions. The incumbent may also be required to move up to twenty-five pounds occasionally.

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.

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.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.