Regulatory Affairs Compliance Senior Manager - Hybrid

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:

• Develop and implement global regulatory strategy for MMS 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 Rest of World
• Ensure QMS requirements are followed and executed consistently from a regulatory affairs 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 approval 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 team of associates and managers

About You: To be successful in this role, we require:

• Minimum bachelor's degree in RA, QA, engineering, or other science-related field
• Advanced degree (e.g. MS, Life Sciences) 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 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 prioritization, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects while partnering with cross-functional colleagues to identify regulatory innovation
• Demonstrated leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and a willingness to make changes when needed
• Ability to travel globally up to 20% of the time

Salary ranges have been implemented to reward associates fairly and competitively, as well as tosupport recognition of associates' progress, ranging from entry level to experts in their field, andtalent mobility. There are many factors, such as location, that contribute to the range displayed. Thesalary offered to a successful candidate is based on experience, education, skills, and actual worklocation. Salary ranges may vary for Field-based and Remote roles.

$158,300.00 - $261,100.00 USD Annual

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

USA CA - Irvine Laguna Canyon

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
$158,300.00 - $261,100.00 USD Annual