BD Nogales Norte
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Sr. Regulatory Affairs Specialist
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BD Nogales Norte The Sr. Regulatory Affairs Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes. The Sr. Regulatory Affairs Specialist interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk. Job Responsibilities Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met. Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market. Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements. Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval. Point of contact for FDA, EU notified bodies, and other regulatory agencies on submissions and other issues. Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communicates changes to global regions and supports preparation of global notifications as needed. Understands fundamental global regulatory requirements and different regulatory pathways. Stays informed of new regulations and changes to existing regulations and communicates to project teams. Maintains regulatory databases and systems Mentors other regulatory colleagues Minimum Qualifications Bachelor's degree or higher, preferably in a scientific discipline 4 years Regulatory Affairs experience in the medical device industry preferred Preferred Qualifications Master's degree in Regulatory Affairs preferred Regulatory Affairs Professional Society (RAPS) certification preferred Excellent written and verbal communication skills Excellent problem solving and analytical skills Detail-oriented, with a focus on accuracy and completeness Excellent organization skills; able to manage multiple tasks and meet timeline commitments Ability to work in a team-oriented, fast-paced environment Demonstrated ability to analyze, interpret, review, and summarize scientific, technical, and regulatory information Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions Knowledge of product development and medical device quality system regulations Experience with product development processes and design control Ability to mentor and teach other regulatory associates Proven prior experience owning and managing the end-to-end process of authoring, submitting and obtaining regulatory approvals/clearances (510(k)s), including addressing and responding to deficiencies from regulatory agencies Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint) At BD, we prioritize on-site collaboration. 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 recognizing the importance of flexibility. Remote or field-based positions will have different workplace arrangements indicated in the job posting. Vaccination requirements may apply in certain locations, with accommodations considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and helps each other be great, do whats right, and improve every day. BD is an Equal Opportunity Employer. To learn more about BD, visit the Careers site. Salary information is provided as a range and may vary by location and experience. Primary Work Location: USA NJ - Franklin Lakes; Additional Locations: USA UT - Salt Lake City #J-18808-Ljbffr
Sr. Regulatory Affairs Specialist
role at
BD Nogales Norte The Sr. Regulatory Affairs Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes. The Sr. Regulatory Affairs Specialist interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk. Job Responsibilities Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met. Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market. Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements. Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval. Point of contact for FDA, EU notified bodies, and other regulatory agencies on submissions and other issues. Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communicates changes to global regions and supports preparation of global notifications as needed. Understands fundamental global regulatory requirements and different regulatory pathways. Stays informed of new regulations and changes to existing regulations and communicates to project teams. Maintains regulatory databases and systems Mentors other regulatory colleagues Minimum Qualifications Bachelor's degree or higher, preferably in a scientific discipline 4 years Regulatory Affairs experience in the medical device industry preferred Preferred Qualifications Master's degree in Regulatory Affairs preferred Regulatory Affairs Professional Society (RAPS) certification preferred Excellent written and verbal communication skills Excellent problem solving and analytical skills Detail-oriented, with a focus on accuracy and completeness Excellent organization skills; able to manage multiple tasks and meet timeline commitments Ability to work in a team-oriented, fast-paced environment Demonstrated ability to analyze, interpret, review, and summarize scientific, technical, and regulatory information Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions Knowledge of product development and medical device quality system regulations Experience with product development processes and design control Ability to mentor and teach other regulatory associates Proven prior experience owning and managing the end-to-end process of authoring, submitting and obtaining regulatory approvals/clearances (510(k)s), including addressing and responding to deficiencies from regulatory agencies Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint) At BD, we prioritize on-site collaboration. 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 recognizing the importance of flexibility. Remote or field-based positions will have different workplace arrangements indicated in the job posting. Vaccination requirements may apply in certain locations, with accommodations considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and helps each other be great, do whats right, and improve every day. BD is an Equal Opportunity Employer. To learn more about BD, visit the Careers site. Salary information is provided as a range and may vary by location and experience. Primary Work Location: USA NJ - Franklin Lakes; Additional Locations: USA UT - Salt Lake City #J-18808-Ljbffr