Job Description: The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices.
Responsibilities: - 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.
Requirements - Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred.
- Minimum of 7-10 years of experience in regulatory affairs within the medical device industry.
- Proven track record of leading and successfully obtaining 510(k) and clearances/approvals.
- Experience in interacting with FDA and other regulatory agencies.
- In-depth 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 problem-solving skills.
- bility to work collaboratively in a cross-functional team environment.
- Detail-oriented with strong organizational skills.
