Staff Specialist, Regulatory Affairs

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.

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 communicate 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

Mentor other regulatory colleagues

Minimum Requirements :

• Bachelor's degree or higher
• 6-8 years' Regulatory Affairs experience in the medical device industry
• Experience leading communications with FDA, EU notified bodies, and other regulatory agencies
• Experience with US 510(k), CE mark (EU MDD / MDR), and other international requirements and submissions
• Proven experience owning and managing the end-to-end process of regulatory approvals / clearances
• Experience with product development processes and design controls
• Excellent written and verbal communication skills
• Strong negotiation skills
• Problem-solving and analytical skills
• Detail-oriented with organizational skills to manage multiple tasks
• Ability to work in a team-oriented, fast-paced environment
• Proficiency in Microsoft Office tools

Preferred Qualifications :

Physical demands :

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.

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.

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.