Sr. Regulatory Affairs Manager

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.
• Ability to work collaboratively in a cross-functional team environment.
• Detail-oriented with strong organizational skills.