Manager - Regulatory Affairs (Hybrid)
Becton Dickinson NA

Job Info

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Job Description Summary
As Manager of RA you will be responsible for is 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 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
• Provides 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 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 ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

$112,900.00 - 186,000.00 USD Annual

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.

Primary Work Location
USA RI - Warwick

Additional Locations
USA AZ - Tempe Headquarters, USA CA - Irvine Neomend, USA CA - San Diego (BDB), USA CA - San Diego (IDS), USA GA - Covington BMD, USA IL - Vernon Hills, USA MA - Woburn, USA MD - Sparks - 39 Loveton Circle, USA NC - Research Triangle Park, USA NJ - Franklin Lakes, USA PR - Humacao, USA UT - Salt Lake City, USA UT - Sandy

Work Shift

At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information
$112,900.00 - $186,000.00 USD Annual

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