Job Description Summary
Regulatory Affairs (RA) Senior Manager is responsible for the preparation and documentation of regulatory submissions to government agencies. This includes activities such as preparation and/or oversight of clearance/approval/registration/licensure documentation for regulatory submissions to government agencies (worldwide), performing tasks associated with obtaining and maintaining product clearances licenses and registrations, and leading pre-market and post-market activities. Normally receives no instructions on routine work, general instructions on new assignments. May provide leadership by assigning work and resolving complex problems. The RA Senior Manger works on problems of high complexity and diverse scope, in which data analysis requires evaluation of identifiable factors.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.
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.
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
Manage, plan, and coordinate work of Regulatory Affairs department across multiple project lines and/or platforms.
Develops, maintains and strengthens partnerships with others inside and outside the organization.
Participate as an active, engaged global team member on core projects and/or provide guidance/strategy. Understands global regulatory requirements and develops different regulatory pathways and communicate options to cross functional teams. Understands regulatory trends.
Lead others in U.S. 510(k) and EU technical file preparation and regulatory activities per plan with minimal supervision. Responsible for obtaining clearance and approval including negotiation with the regulators in US and EU with minimum supervision.
Develop, monitor, and report to senior management key performance indicators
Provide regulatory expertise in US and EU regulatory requirements
Monitor changes in US and EU regulatory requirements and anticipates needed actions.
Ensure RA department processes and procedures related to regulatory responsibilities are compliant, current and efficient.
Review product labeling, advertising and promotional materials
Mentor regulatory associates and develop for career advancement.
Provide Regulatory support to regulatory inspections, such as ISO and FDA audits.
Lead cross-functional or cross-business teams to address process improvements, major international regulatory changes or initiatives (e.g., compliance with new registration requirements in developing markets), or professional development with minimum supervision.
Possesses deep understanding of how people, teams and the organization work.
Understands BD culture and values and reflects them in his/ her own behavior.
Required Qualifications:
Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices.
Demonstrated self-starter, and highly motivated
Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results
Demonstrated ability to effectively formulate and drive change
Experienced in continuous improvement projects, project management, product development processes, and design control.
Ability to be effective in complex projects with ambiguity and/or rapid change
Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators.
Computer literacy (SAP, PC, Microsoft Word/Excel/PowerPoint)
Orientation for detail work product, with emphasis on accuracy and completeness.
Familiar with Design control documents; History Files, Device History Records, QC testing, Stability reports, etc.
Knowledge of medical device testing methods and statistics, as applicable.
Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.
Education and/or Experience:
Bachelor’s degree required or advanced degree in technical area such as biology, chemistry, engineering, or medical-related field.
Minimum of six years regulatory affairs or related experience.
Minimum of two years managerial experience.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
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.
United States
