Job Description Summary

The Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on global regulatory strategy and submissions for implantable and absorbable devices. Under the mentorship of the Senior Regulatory Affairs Manager, the position will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations globally. The RA Specialist will also provide support related to currently marketed devices and help ensure the company’s regulatory compliance status. This is a hybrid position where the candidate is required to be in the office a minimum of 3 days a week. Office location is Warwick, Rhode Island.

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.

Responsibilities

• Liaison with regional RA, platform RA and other cross functional colleagues to provide accurate country specific regulatory documentation per timelines.

• Assists and/or has ownership in preparation of dossiers and submission packages for regulatory agencies.

• Maintains regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s).

• Inform the RA team of new and changing country specific regulations and requirements.

• Coordinate and respond to requests for product information from Region RA colleagues.

• Assists in updates to standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

• May participate in regulatory body audits, as related to respective product line(s) and/or region(s).

Qualifications

• Bachelor’s degree or equivalent in a technical field such as biology, chemistry, engineering or medical related field, or equivalent combination of related education and experience.

• Must have strong communication skills (both written and verbal).

• Must be able to balance multiple tasks with attention to detail with limited supervision.

• Must have ability and desire to travel as needed.

• Must have the desire to learn and grow in a fast-paced medical device company.

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. 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.

To learn more about BD visit  https://bd.com/careers

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.

PDN

Primary Work Location

USA RI - Warwick

Additional Locations

Work Shift

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.