Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
Job Description
We arethe makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, andit’sno 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 whichyou’llbe supported to learn,growand become your best self. Become amaker of possiblewith us.
Job Summary
This position is responsible for implementing BD's regulatory policies and procedures related to multiple projects within the business unit. The Regulatory Affairs Manager will be responsible for managing other Regulatory associates and directly supporting projects to bring new and modified medical devices to market and ensure ongoing compliance. You and your direct reports will participate in cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, lead interactions with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes. This role interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.
The ideal candidate will have excellent organizational, problem solving and analytical skills: able to manage multiple tasks and meet timeline commitments. Having excellent written and verbal communication skills; can communicate across cultures; collaborate with a cross-functional team; effectively interact with technical and legal associates; and negotiate with Regulators is pivotal for success in this opportunity. Having the ability to work in a team-oriented, fast-paced environment; develop, mentor, and coach regulatory team members and being effective in complex projects with ambiguity and rapid change is key!
Job Responsibilities
Coordinates RA activities for direct reports
Manages RA responsibilities and functional goals which may consist of FDA and BD required filings and new information dissemination
Makes preliminary determinations regarding the appropriate US and/or International regulatory submission requirements for new or modified products
Reviews and approves documentation Change Requests, labeling artwork changes, recall and FDA inspection assistance, as defined by BD procedures
Facilitates FDA submission activities and creates 510(k) rationales, global submissions and/or rationales
Writes new product submissions, prepares and/or contributes to FDA and required BD reports, and ensures RA department support on new product teams
Keeps knowledge of FDA and/or global requirements current by attending industry, FDA, and corporate seminars, when possible
Acts as alternate liaison for quality system audits and inspections
Will develop global regulatory strategies
Supervises maintenance of US, CE, and international documentation
Involved with the coordination and management of EU MDR technical file audits; and supports other external and internal audits
Minimum Requirements
Bachelor's degree in a scientific field
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
Experience with product development processes and design controls
Proficient with Microsoft Office tools (including Word, Excel, PowerPoint)
Knowledge of product development and medical device quality system regulations
Preferred Experience/Skills
Master's degree in Regulatory Affairs
1+ years’ management experience
Regulatory Affairs Professional Society (RAPS) certification
Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements
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 tomaintainour 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 beindicatedin 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/orrequired. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be consideredpursuant toapplicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions andcontributionsand that encourages you to bring your authentic self to work.It’salso a place where we help each other be great, we dowhat’sright, we hold each otheraccountable, andlearn 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 withthe imaginationand drive to help us reinvent the future of health. At BD,you’lldiscover 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 Companyisan 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 otherlegally-protectedcharacteristics.
Required Skills
Optional Skills
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Primary Work Location
USA UT - Salt Lake City BASAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter