Job Description Summary
As Manager, Regulatory Affairs, you will provide leadership to the MMS -Pharmacy Automation platform team. You will contribute to the development of MMS - RA strategic and operational plans through sound assessment related to regulatory pathways and risks, and regulatory programs. Such assessments may influence the scientific or technical direction of product design and/or development in support of worldwide registrations. Candidates may report to any BD office in the U.S, England and/or Canada 3 days a week.
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.
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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.
Key responsibilities will include:
- Provides pre-market regulatory leadership to MMS-PA business
- Directs premarket regulatory affairs activities which may include interactions between MMS-PA and Notified Body, as well as government agencies outside of the US and EU as required
- Contributes to the development of MMS-PA strategic and operational plans; regulatory pathways and risks, and sound regulatory programs
- Ensures functional excellence to achieve timely worldwide clearance, approval, registration, and licensure.
- Responsible for talent development for the MMS-PA premarket Regulatory Affairs group; supervises and mentors RA associates
- Plays an active role in external industry group efforts to shape policies, guidance, and standards that are of strategic importance to MMS-PA
- Works with cross functional teams, coordinates, directs and advises the preparation of global regulatory dossier and submissions, including EU Technical Files for CE mark (e.g., Machinery Directive), and materials required for global registration of products and monitors and guides associate submission activities.
- Provides high degree of regulatory expertise and experience to MMS-PA's new product development programs, serving as a Core Team advisor and champion for MMS-PA's Global Product Development System (GPDS)
- Serves as a regulatory expert for labeling and promotional materials review, supports regulatory standards development, experimental designs, and data analysis as they relate to registration and commercialization of PA products
- Instills a culture of continuous improvement by identifying and implementing improvements to support and achieve functional excellence
About you: To be successful in this role, you require:
- Experienced knowledge in US and global electrical equipment regulations
- Demonstrated ability to perform critical thinking at a high level of proficiency, able to exercise independent judgement and discretion within a broadly defined range of policies and practices
- Demonstrated ability to deliver desired outcomes via innovative ideas and approaches
- Advanced verbal, written, presentation and negotiation skills
- Leads multiple long-term complex, projects without direct supervision
- Excellent leadership skills with ability to develop, influence and lead others
- Experienced with continuous improvement projects, project management, product development processes, and design control
Education and Experience:
- B.A. or B.S. degree in health science or life science field (biology, microbiology, chemistry, engineering, medical technology, etc.)
- MS degree in health science, regulatory affairs, or applicable discipline a plus
- RAC/RCC Certification preferred
- Minimum 4 years directly applicable recent regulatory affairs work experience (e.g., IVD 510(k), PMA, de novo, IVDD and IVDR compliant tech files, etc.) in a medical device company, and a minimum of 4 years in regulatory affairs or a related discipline
- Minimum of 2 years of people management experience
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.
PDN
Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
GBR Winnersh - Eskdale Road, USA NC - Durham - Roche Drive
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 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.
Salary Range Information
$121,100.00 - $199,800.00