BD
Manager - Regulatory Affairs (Hybrid)
BD, Warwick, Rhode Island, us, 02888
Job Description Summary
As Manager of RA, you will be responsible for establishing processes, strategies, and assessing business needs in the second largest market for BD Surgery, which consists of the European Union, United Kingdom, Middle East, and Africa (EMEA). As the largest regulated region, the role will lead and direct a team at establishing best approaches for Surgery RA to gain and maintain access in a region with unprecedented regulatory requirement changes. The role will be responsible for guiding the Surgery RA in this area but also supporting the ARR team in new product development strategies as well as sustaining and productivity initiatives. The role is specific to both the Advanced Repair and Reconstruction (ARR) platform as well as the Surgery Business Unit (BU). Candidates must be able to work on-site three days per week in one of our US BD locations.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.Primary Responsibilities:Provide leadership in strategizing global activities within the EMEA region including owning international registrations and acting as a liaison with ARR and Biosurgery commercial teams for decision making on maintenance of current commercial products as well as the introduction of new products.Provide inputs and review of global dashboards and establish Key Driver Goals for the Surgery RA team that are related to value driving initiatives within the region.Develop staff by making accurate assessments of individuals’ capabilities and performance, and providing feedback, coaching, guidance, and mentoring.Establish and improve processes for the Surgery BU in the areas of EU Technical Documentation, EU re-certification, and EU change control.Act as Surgery BU lead with EU Notified Bodies and strategically engage with ARR and Surgical Solution platforms for prioritization, direction, and escalation needs.Build forums and communication plans to keep Surgery RA team updated on new and changing regulations, interpretations, or expectations of EMEA regulatory bodies.Act as RA EU MDR lead for Surgery RA and provide strategic direction for compliance and input into decisions required including implementation plans.Support ARR RA and Platform cross-functional partners to review requirements related to sustaining programs and aid senior management in recommendations on resourcing needs or process improvements that support the Surgery BU in meeting BD-wide excellence numbers.Provide support in multiple areas that could include R&D Innovation, NPD, and or Commercial initiatives.Provide regulatory SME expertise during internal/external audits and inspections.About you:Minimum 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.Minimum of Five (5) years Regulatory Affairs experience with medical devices with proven success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE, Pre-submissions) to the FDA and other global regulatory agencies, OR Seven (7) years experience with medical devices in other functions (e.g., QA, R&D, PMO, MA, etc.) with demonstrated support of regulatory submission development and approval from EU Notified Bodies, FDA, and other global regulatory agencies.Minimum of one year managerial experience.Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices.Demonstrated organizational, planning, and program management skills, including an action orientation, a sense of urgency, and a driver for results.Experienced in continuous improvement projects, project management, product development processes, and design control.Excellent written and verbal communication skills including the ability to communicate across geographies; work with others in a team environment; and the ability to have effective interactions with technical personnel (scientific and legal); and negotiate with regulators.Proficient in using Microsoft Word, Excel, and PowerPoint.Preferred: RAC, PMP Certification and/or Regulatory Information Management system (RIM) experience.Preferred: previous experience managing people across geographies.Preferred: previous experience with Implantable medical devices.Salary Range Information$112,900.00 - $186,000.00 USD Annual
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As Manager of RA, you will be responsible for establishing processes, strategies, and assessing business needs in the second largest market for BD Surgery, which consists of the European Union, United Kingdom, Middle East, and Africa (EMEA). As the largest regulated region, the role will lead and direct a team at establishing best approaches for Surgery RA to gain and maintain access in a region with unprecedented regulatory requirement changes. The role will be responsible for guiding the Surgery RA in this area but also supporting the ARR team in new product development strategies as well as sustaining and productivity initiatives. The role is specific to both the Advanced Repair and Reconstruction (ARR) platform as well as the Surgery Business Unit (BU). Candidates must be able to work on-site three days per week in one of our US BD locations.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.Primary Responsibilities:Provide leadership in strategizing global activities within the EMEA region including owning international registrations and acting as a liaison with ARR and Biosurgery commercial teams for decision making on maintenance of current commercial products as well as the introduction of new products.Provide inputs and review of global dashboards and establish Key Driver Goals for the Surgery RA team that are related to value driving initiatives within the region.Develop staff by making accurate assessments of individuals’ capabilities and performance, and providing feedback, coaching, guidance, and mentoring.Establish and improve processes for the Surgery BU in the areas of EU Technical Documentation, EU re-certification, and EU change control.Act as Surgery BU lead with EU Notified Bodies and strategically engage with ARR and Surgical Solution platforms for prioritization, direction, and escalation needs.Build forums and communication plans to keep Surgery RA team updated on new and changing regulations, interpretations, or expectations of EMEA regulatory bodies.Act as RA EU MDR lead for Surgery RA and provide strategic direction for compliance and input into decisions required including implementation plans.Support ARR RA and Platform cross-functional partners to review requirements related to sustaining programs and aid senior management in recommendations on resourcing needs or process improvements that support the Surgery BU in meeting BD-wide excellence numbers.Provide support in multiple areas that could include R&D Innovation, NPD, and or Commercial initiatives.Provide regulatory SME expertise during internal/external audits and inspections.About you:Minimum 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.Minimum of Five (5) years Regulatory Affairs experience with medical devices with proven success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE, Pre-submissions) to the FDA and other global regulatory agencies, OR Seven (7) years experience with medical devices in other functions (e.g., QA, R&D, PMO, MA, etc.) with demonstrated support of regulatory submission development and approval from EU Notified Bodies, FDA, and other global regulatory agencies.Minimum of one year managerial experience.Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices.Demonstrated organizational, planning, and program management skills, including an action orientation, a sense of urgency, and a driver for results.Experienced in continuous improvement projects, project management, product development processes, and design control.Excellent written and verbal communication skills including the ability to communicate across geographies; work with others in a team environment; and the ability to have effective interactions with technical personnel (scientific and legal); and negotiate with regulators.Proficient in using Microsoft Word, Excel, and PowerPoint.Preferred: RAC, PMP Certification and/or Regulatory Information Management system (RIM) experience.Preferred: previous experience managing people across geographies.Preferred: previous experience with Implantable medical devices.Salary Range Information$112,900.00 - $186,000.00 USD Annual
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