Manager of Regulatory Affairs that oversees MMS Infusion products and their associated software & accessories.
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 creativity 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 ground-breaking 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.
About the role
The Manager of Regulatory Affairs reports directly to the Associate Director of Regulatory Affairs Process Quality. This position is responsible for supporting MMS Infusion products and their 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. The Manager will be responsible for the hiring, training, and career development of their reports.
Essential functions include, but are not limited to:
Supervise and develop direct report associates to ensure regulatory compliance
Problem address and raise regulatory and compliance issues to upper level management as vital
Provide effective leadership and team development, effective communication, and quick responses to customers
Drive continuous improvement in internal processes and customer happiness
Identify, develop, and mentor hard-working regulatory talent
Develop and implement global regulatory strategy for BD MMS Infusion products
Support regulatory effort to align with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
Support the monitoring, interpreting, and implementing of current and new regulatory requirements and international standards for U.S., EU., and RoW
Assure that QMS requirements are followed and completed consistently from RA perspective
Be responsible for efforts for Technical File creation and remediation, collaborating 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
Assists 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
Performs other duties and assignments as required
To be successful in this role, we require:
Knowledge of global Regulatory Affairs requirements, regulations and standards
Applied knowledge of IEC 62304, IEC 60601, ISO 14971
Strong organizational skills
Strong prioritizing, interpersonal, communication, and analytical skills and the ability to multi-task disparate projects
Ability to represent Regulatory Affairs in multiple environments (e.g. Marketing, R&D, and compliance) and work with all levels of personnel, including VP/GM
Partnering with cross-functional colleagues to find opportunities for regulatory innovation
Read, analyze, and interpret regulatory literature and documents and efficiently communicate information to peers and management
Ability to work within a team environment and independently with minimum supervision
Identify and communicate risks and mitigations associated with global regulatory strategies to cross-functional collaborators and act upon these items appropriately as an RA member
Confirmed leadership courage through willingness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed
Education
Bachelor's degree in RA, QA, engineering, or other science related field
Advanced degree (e.g. MS, PhD) preferred
RAPS RAC certification preferred
Experience
Minimum of 5 years of directly related Regulatory Affairs experience in complex medical devices containing software
Minimum of 3 years of personnel management (direct report) experience including performance evaluations/improvement, and career development
Software experience such as SaMD/SiMD, applied experience with IEC 62304, FDA Mentorship on Cybersecurity in Medical Devices
Regulatory and Quality Information Management systems such as SAP, RIM, or related systems
Digital literacy MS Word, Excel, PowerPoint, Teams
Project Management experience
Ability to travel globally up to 10-15% of the time.
This role is a fully remote position.
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 CA - San Diego Bldg A&B
Additional Locations
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.
