Job Description Summary
As Senior Manager, International Regulatory Affairs, you will be responsible for Central Asia, South Asia, and Japan (CASAJ) and Greater China product activities related to submissions and registration. You will work effectively with our MDS platform and cross functional team members to provide submission/registration documentation while considering strategic planning and revenue drivers. You will manage priorities and provide associate guidance and development.
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 transformative solutions that turn dreams into possibilities.
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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 regulatory strategies for new and existing products to ensure compliance with international regulations.
- Coordinate, prepare, and review regulatory submissions for international projects.
- Maintain current knowledge of relevant Gr. Asia regulations, including proposed and final rules, and ensure the MDS International RA CoE team is updated on any changes.
- Manage and control regulatory documentation, ensuring it meets all regulatory requirements.
- Work closely with other departments, such as Research and Development, Quality Assurance, and Commercial teams, to ensure global registration compliance and license support.
- Identify and assess regulatory risks and provide guidance on regulatory requirements.
- Train staff in regulatory policies, procedures, and systems, including product development and ERP systems.
- Assist in regulatory audits and inspections, ensuring all internal procedures and standards are met.
About You:
- Minimum BA/BS required.
- Minimum 8 years regulatory affairs experience; or a combination of regulatory affairs, quality or engineering experience is acceptable.
- Must have medical device international product submission and registration requirement knowledge.
- Proven experience in Design Controls, GPDS, and ERP systems (SAP and Master Control.)
- Must have the ability to develop and mentor others within the department promoting open communication and feedback.
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.
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Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
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