Senior Regulatory Affairs Manager
Senior Regulatory Affairs Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Prepare review and submit regulatory documents to FDA.
- Manage and oversee the regulatory submission process ensuring timely and successful clearances/approvals.
- Ensure that all products comply with applicable regulatory requirements including FDA regulations and ISO standards.
- Provide regulatory guidance to R&D team during product development life cycle.
- Stay updated on changes in regulatory requirements and communicate potential impacts to the organization.
- Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways.
- Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines.
- Represent the company in meetings with regulatory agencies and external partners as needed.
- Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies.
- Masters degree in Regulatory Affairs Life Sciences Engineering or a related field; advanced degree preferred.
- Minimum of 710 years of experience in regulatory affairs within the medical device industry.
- Proven track record of leading and successfully obtaining 510(k) and De Novo clearances/approvals.
- Experience in interacting with FDA and other regulatory agencies.
- Indepth knowledge of FDA regulations 21 CFR Part 820 ISO 13485 and other applicable medical device regulations.
- Strong leadership and project management skills with the ability to manage multiple projects and priorities.
- Excellent communication negotiation and problemsolving skills.
- Ability to work collaboratively in a crossfunctional team environment.
- Detailoriented with strong organizational skills.
Employment Type
Full Time
