Associate Director Regulatory Affairs
4 weeks ago
Join to apply for the Associate Director Regulatory Affairs role at BD (Tissuemed Ltd) .
We are one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities.
The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. Responsibilities include, but are not limited to, the development and implementation of regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations including variations and renewals, interacting with global internal stakeholders and external consultants/service providers in support of registration activities, and developing and maintaining documentation for compliance programs such as labeling, promotional material review and other regulatory requirements.
Lead regulatory submission activities for various initiatives.
Assist in the maintenance of departmental systems used to track projects and ongoing operational activities.
Bachelors degree in science, STEM, or engineering.
Minimum of 10 years of relevant experience in the medical device industry within Quality and/or R&D, including at least 5 years in Regulatory Affairs. Must have handson experience with complex medical device systems and software, specifically ClassII or higher devices.
Minimum of 12 years of proven experience in people management, including team leadership and performance oversight.
Advanced degree, masters degree or higher preferred with a focus in a scientific discipline.
Regulatory Affairs Certification (RAC) preferred.
Project Management Certification preferred.
Travel up to 20% domestically and internationally may be required.
At BD, we prioritize onsite collaboration because we believe it fosters creativity, innovation and effective problemsolving, which are essential in a fastpaced healthcare industry. Remote or fieldbased positions will have different workplace arrangements indicated in the job posting.
For certain roles at BD, employment is contingent upon the Companys receipt of sufficient proof that you are fully vaccinated against COVID19. In some locations, testing for COVID19 may be available and/or required. Consistent with BDs Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
We welcome people with the imagination and drive to help us reinvent the future of health. At BD, youll 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
We evaluate applicants without regard to 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, and other legally protected characteristics.
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