Melio Life Science has partnered with a leading innovator in the medical device industry, committed to advancing healthcare through cutting-edge technologies. They are seeking a highly skilled and experienced Senior Regulatory Manager to join their dynamic team.
Overview
The successful candidate will play a pivotal role in ensuring compliance with regulatory requirements and guiding their products through the regulatory approval process.
Key Responsibilities:
Develop and implement regulatory strategies for new and existing medical devices.
Prepare and submit regulatory filings, including 510(k)s, PMAs, and other regulatory submissions, to regulatory authorities such as the FDA.
Ensure ongoing compliance with global regulatory standards and requirements.
Collaborate with the quality assurance team to maintain and enhance the company's quality management system.
Work closely with R&D, clinical, quality, and manufacturing teams to ensure regulatory requirements are considered throughout the product lifecycle.
Lead and manage a team of regulatory professionals, providing guidance, mentorship, and support.
Desirable:
At least 2 years of EU MDR/ SaMD experience.
Qualifications:
Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
8+ years of experience in medical device regulatory affairs.
In-depth knowledge of FDA regulations and international regulatory requirements.
Experience with managing teams of at least 5 people.
3 years of managerial experience.
Proven track record of successful regulatory submissions and approvals.
Strong project management and organizational skills.
Excellent communication and interpersonal skills.