Senior Regulatory Affairs Manager - Sparks, MD or Franklin Lakes, NJ

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.

About the role :

Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit.

This position directs multiple projects of their functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to staff and teams to achieve rapid worldwide clearance / approval / registration of BDDS products with desired claims.

Preferred Location Sparks, MD (Additional option Franklin Lakes, NJ)

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Key responsibilities will include :

Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to FDA and other regulatory agencies.

• Identifies and communicates potential risks and mitigations associated with regulatory strategies.
• Represents BDDS RA function in interactions / negotiations with U.S. regulatory agencies.
• Represents BDDS RA function in external activities benefiting BD, including trade associations, professional organizations, and standards development organizations.
• Responsible for monitoring, interpreting, and implementing current and new regulatory requirements for U.S. and EU.
• Designs and implements training on regulatory issues for staff and for to cross-functional groups across BD.
• Provides recommendations for BDDS Regulatory Affairs functional budget.

About you :

• Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
• Demonstrates in-depth understanding of advanced technical / scientific principles that relate to a specific product line.
• Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions / dossiers (e.

g., 510(k), IDE, PMA, EU Technical Files).

• Demonstrated success in developing strong working relationships with regulators.
• Knowledge of regulations applying to medical devices and in vitro diagnostic devices including software in the U.S., and EU.

Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.

Highly Complex. This position plays in an important role in getting products to market in a timely way with the desired claims.

Role requires ability to analyze complex regulatory issues, to develop cogent approaches to resolving / addressing issues, and to negotiate with regulatory authorities.

Erroneous or incomplete recommendations may cause delays in meeting business objectives.

Education and experience required :

• B.S. or B.A. degree in a technical discipline (chemistry, biology, microbiology, or molecular microbiology preferred).
• RAPS RAC (Devices, or U.S. prior to 2020) preferred
• Minimum six years of directly related regulatory experience in the medical device and / or in vitro diagnostic device area(s) including experience with software as a medical device.

Click on Apply if this sounds like you!

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 learn and 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. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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.