Senior Regulatory Affairs Specialist - hybrid - Covington, Georgia Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities, with a primary focus on EU/MDR, along with supporting all other geographical regions registrations. In addition, this position will help support RA management.
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.
Senior Regulatory Affairs Specialist -
*** This is a Hybrid role of which will require employee to be onsite in Covington, GA 3 days a week- Covington, Georgia. Candidate must reside in a daily commutable distance to our Covington, GA location***
Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities, with a primary focus on EU/MDR, along with supporting all other geographical regions registrations. In addition, this position will help support RA management.
Key responsibilities will include:
Regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents).
Prepare &/or revise STED technical files for CE marking activities and notified body interaction to support EU/MDR product maintenance, as required.
Provide support and guidance for post market activities including remedial actions, labeling.
Prepare and support 510(k) &/or change assessments, as required.
To be successful in this role, you will work independently by applying your written and analytical skills to create technical documents, in some cases to cover design changes and change notifications for BD's wide range of medical devices. You will also demonstrate your communication skills to work optimally with internal customers and team members as well as external auditors.
Education and Experience required:
Preferred
Regulatory Affairs Certification (RAC) preferred.
Author and support 510(k), Tech File / STED File submissions as required.
Provide regulatory support and guidance for post market activities and labeling review.
Potential limited travel required - 15%.
Required
BS required, preferably in a Scientific Field or Regulated Industry
Minimum of 4 years' experience in Regulatory (to include some experience within medical device); experience in areas of product registration, compliance or quality systems highly preferred
Must demonstrate ability to provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control assessments, timeline development, and reviewing submission related documents).
Familiarity with STED and/or technical file updates for CE marking activities and notified body interaction to maintain EU/MDR product registrations required
Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
Must be able to prioritize and handle several projects concurrently.
Must be self-motivated by working independently and having the ability to take ownership of their responsibilities.
Must have knowledge of the U.S. and European medical device regulations.
Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
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.
