Job Description Summary

The Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory strategy and submissions for Implantable and Absorbable devices. Under the mentorship of the Senior Manager of Regulatory Affairs, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions. The RA Specialist will provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents). The incumbent should have demonstrated success working in cross-functional teams, excellent written and verbal communication skills with an ability to see the big picture.
This on-site role will be based at the BD Manufacturing Facility in Humacao, Puerto Rico and will require engagement with cross-functional colleagues at the plant as well as with colleagues from the Design Center.

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 Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory strategy and submissions for Implantable and Absorbable devices. Under the mentorship of the Senior Manager of Regulatory Affairs, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions. The incumbent should have demonstrated success working in cross-functional teams, excellent written and verbal communication skills with an ability to see the big picture.

This on-site role will be based at the BD Manufacturing Facility in Humacao, Puerto Rico and will require engagement with cross-functional colleagues at the plant as well as with colleagues from the Design Center globally located.

Responsibilities:

• Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)

• Responsible to prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required

• Prepare and update STED technical files for CE marking activities and notified body interaction

• Identify and communicate appropriately quantified risks and mitigations associated with regulatory strategies to cross-functional stake holders.

• Provide cross-functional support for regulatory submissions and compliance, including approval of product labeling, promotional, and advertising materials; review of clinical and human factors protocols; regulatory leadership on business continuity projects and writing/updating standard operating procedures, work instructions, and policies.

• Provides regulatory support during internal/external audits and inspections.

Education and Experience:

• B.A. or B.S. degree in a technical field preferred (e.g., engineering, biology, chemistry, health science). B.A. or B.S. in other field acceptable with appropriate level of experience.

• Two years Regulatory Affairs experience with medical devices or in vitro diagnostic devices OR Four years experience with medical devices in other functions (e.g., Quality, R&D, etc.)

Knowledge and Skills:

• Bilingual in English and Spanish (Verbal, Writing, Reading)

• Excellent written and verbal communication skills

• Self-motivated, work independently and have the ability to take ownership of responsibilities

• Must be able to prioritize and handle several projects concurrently

• Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience

• Proficient in using Microsoft Word, Excel and PowerPoint

• PMP certification desired

• Previous experience managing class III devices preferred

• Previous experience working with implantable medical devices preferred

• Previous experience working with textiles preferred

Scope and Impact of Position

Key support for

• Business Unit Surgery ISC Team

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. 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. 

Required Skills

Optional Skills

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Primary Work Location

USA PR - Humacao

Additional Locations

Work Shift