Product Manager, Surgery, SEA

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Product Manager, Surgery, SEA
role at
BD Nogales Norte
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
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 will be supported to learn, grow, and become your best self. Become a maker of possible with us.
Responsibilities
Lead and develop direct report associates to ensure regulatory compliance
Problem solve and escalate regulatory and compliance issues to senior management as vital
Provide effective leadership and team development, effective communication, and quick responses to customers
Drive continuous improvement in internal processes and customer satisfaction
Identify, develop, and mentor impactful regulatory talent
Author and organize regulatory submission content (510(k), Technical Files, etc.)
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, 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 executed consistently from RA perspective
Oversee 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
Qualifications
Bachelor’s degree in RA, QA, engineering, or other science related discipline
Advanced degree (e.g. MS, PhD) preferred
RAPS RAC certification preferred
Minimum of 10 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field
Minimum of 7 years of personnel management (direct report) experience including performance evaluations/improvement, and career development
Software experience including SaMD/SiMD is a plus
Regulatory and Quality Information Management systems such as SAP, RIM, or related systems
Digital literacy MS Word, Excel, PowerPoint, Teams
Project Management experience
Knowledge of global Regulatory Affairs requirements, regulations and standards
Experience authoring regulatory submissions (US and Global)
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
Ability to partner with cross-functional colleagues to identify opportunities for regulatory innovation
Read, analyze, and interpret regulatory literature and documents and effectively 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
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 10% of the time
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
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.
Salary Range Information
$179,200.00 - $322,500.00 USD Annual
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