Senior Manager, Regulatory Affairs Remote

* Summary
• As Sr. Manager of Regulatory Affairs, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development, sustaining, and end of life activities. This role is a fully remote position.
•
• 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 its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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 youll be supported to learn, grow and become your best self. Become a
• maker of possible
• with us.
• Primary Responsibilities:
• + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non-Medical device products and software
• Lead regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
• Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW
• Support QMS requirements are followed and executed consistently from RA perspective
• Oversee efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content
• Support regulatory impact assessments for change controls and other RA/QA items from a review and approve level
• Assist in preparing, auditing, editing, and publishing registration documentation as needed
• Support business export control (BEC) listing of product for release globally per RA requirements
• Support the review and approval of product labeling, promotional, and advertising materials as needed
• May supervise a staff of associates and managers
• About You: To be successful in this role, we require:
• + Minimum bachelors degree in RA, QA, engineering, or other science related discipline
• Advanced degree (e.g. MS, Life Sciences) preferred
• RAPS RAC certification preferred
• Minimum of 10 years of strong Regulatory Affairs/Compliance experience in medical devices
• Minimum of 5 years of supervision (direct report) experience including performance evaluations/improvements and career development is preferred; coaching and mentoring experience is required.
• Software experience including SaMD/SiMD experience
• Project Management experience
• Knowledge of global Regulatory Affairs requirements, regulations, and standards
• Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects
• Excellent interpersonal, communication and analytical skills and the ability to partner with cross-functional colleagues to identify regulatory innovation Demonstrated leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed
• Ability to travel globally up to 5% of the time
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.
• 155,200.00 - 256,800.00 USD Annual
• For certain roles at BD, employment is contingent upon the Companys 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 BDs Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
• CLOAI
• 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. Its also a place where we help each other be great, we do whats 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, youll 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.
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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 CA - San Diego TC Bldg C&D
• Additional Locations
• USA CA - San Jose (Reagents), USA CO - Lakewood, USA GA - Covington BMD, USA IL - Vernon Hills, USA MD - Sparks - 7 Loveton Circle, USA TX - San Antonio
• Work Shift
• At BD, we are strongly committed to investing in our associatestheir 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
• $155,200.00 - $256,000.00 USD Annual