Faites partie de quelque chose de plus grand chez BD. Ici, vous nous aiderez à maintenir nos normes élevées d'un point de vue réglementaire à tous les niveaux, avec un accent particulier sur les soumissions. Cela exige une attention aiguë aux détails, d'excellentes compétences en communication et une passion pour continuer à apprendre et à mettre à jour vos connaissances, ce que nous vous aiderons à faire avec des opportunités d'apprentissage régulières. Ici, vous utiliserez vos connaissances approfondies des réglementations et des exigences de la FDA, du Canada et de l'ISO/MDD entourant les dispositifs médicaux pour atteindre finalement un objectif unique : faire progresser le monde de la santé™. Chez BD, vous pouvez faire une véritable différence d'une personne.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
Job Description
Bachelor's degree or higher, preferably in a scientific discipline
Master's degree in Regulatory Affairs preferred
Regulatory Affairs Professional Society (RAPS) certification preferred
4-6 years Regulatory Affairs experience in the medical device industry
>Excellent communication and organization skills
>Excellent problem solving and analytical skills
>Detail-oriented, with focus on accuracy and completeness
>Ability to manage multiple tasks and meet timeline commitments
>Ability to work in a team-oriented, fast-paced environment
>Demonstrated ability to analyze, interpret, review, and summarize scientific, technical, and regulatory information
>Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements
>Experience working with FDA, EU notified bodies, and other regulatory agencies
>Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
>Working knowledge of ISO 13485 and 21 CFR 820 quality system requirements.
>Experience with product development processes and design control.
>Mentor/teach
>Proven prior experience required owning and managing the end-to-end process of authoring, submitting and obtaining regulatory approvals/clearances (510(k)s), including addressing and responding to deficiencies from regulatory agencies.
>Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)
The Sr. Regulatory Affairs Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes. The Sr. Regulatory Affairs Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.
>Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met.
>Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market.
>Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements.
>Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval.
>Point of contact for FDA, EU notified bodies, and other regulatory agencies on submissions and other issues.
>Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications.
>Communicates changes to global regions and supports preparation of global notifications as needed.
Primary Work Location
IND Bengaluru - Technology CampusAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.