Associate Director, Regulatory Affairs Needed for Global Medical Device Company This Jobot Job is hosted by: Victoria Casal
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Salary: $125,000 - $200,000 per year
A bit about us: Global Medical Device Company
Why join us?- Competitive Base
- Yearly Bonus
- 401K with Match
- Total Rewards Package (including medical benefits, and PTO)
Job Details Job Details:
This position is an integral part of our regulatory team, responsible for leading and managing regulatory strategies and submissions for our on - market medical devices. This role involves a high level of interaction with various departments including Quality, R&D, Clinical, and Manufacturing. The successful candidate will have a strong understanding of international and domestic regulatory requirements for medical devices, including FDA QSR, ISO 13845, 93/42 EEC, CMDR, and MDR.
Responsibilities:
1. Lead and manage regulatory strategies and submissions for medical devices, ensuring timely approvals and market introductions.
2. Oversee the preparation and submission of FDA 510(k) and other regulatory submissions.
3. Ensure compliance with all relevant regulations and standards including FDA QSR, ISO 13845, 93/42 EEC, CMDR, and MDR.
4. Liaise with regulatory authorities for pre-submission discussions, submission follow-up, and issue resolution.
5. Maintain current knowledge of competitive products and regulatory affairs or regulatory compliance issues that may impact product lines.
6. Provide regulatory input and guidance to project teams for product development and changes.
7. Oversee the validation process of medical devices to ensure compliance with regulatory requirements.
8. Work closely with other departments to ensure that all regulatory requirements are met for on-market products.
9. Provide training and guidance to junior staff members in the Regulatory Affairs department.
Qualifications:
1. Minimum of a bachelor’s degree in a scientific or engineering discipline, or equivalent.
2. Minimum of 5 years of experience in regulatory affairs in the medical device industry.
3. Demonstrated experience with FDA 510(k) submissions and ISO 13845.
4. Strong knowledge of FDA QSR, 93/42 EEC, CMDR, and MDR regulations.
5. Experience in the validation of medical devices.
6. Excellent communication and interpersonal skills.
7. Ability to work in a fast-paced, deadline-driven environment.
8. Proven ability to manage multiple projects and tasks simultaneously.
9. Regulatory Affairs Certification (RAC) is preferred but not required
10. Proficiency in English, both written and spoken.
11. Ability to travel as needed.
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