BD (Becton, Dickinson and Company)
Senior Regulatory Specialist
BD (Becton, Dickinson and Company), Covington, Georgia, United States, 30209
Senior Regulatory Specialist - BD (Becton, Dickinson and Company)
Location: Covington, Georgia (Hybrid)Job DescriptionUrology 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.Key Responsibilities: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 and labeling.Prepare and support 510(k) &/or change assessments, as required.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.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 learn more about BD visit
https://bd.com/careersBecton, 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.
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Location: Covington, Georgia (Hybrid)Job DescriptionUrology 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.Key Responsibilities: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 and labeling.Prepare and support 510(k) &/or change assessments, as required.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.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 learn more about BD visit
https://bd.com/careersBecton, 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.
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