Senior Regulatory Affairs Director
2 months ago
Job Title: Senior Regulatory Affairs Leader
About The Mullings Group: A leading consulting firm specializing in medical device regulatory affairs and strategic business development.
Job Summary: We are seeking a highly experienced Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations for our medical device clients.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with FDA regulations and guidelines.
- Lead cross-functional teams to prepare and submit PMA applications, 510(k) submissions, and other regulatory documents.
- Collaborate with clients to understand their business needs and develop tailored regulatory solutions.
- Stay up-to-date with changing regulatory requirements and industry trends.
- Provide regulatory guidance and support to clients throughout the product lifecycle.
Requirements:
- Proven experience in regulatory affairs, preferably in the medical device industry.
- Strong knowledge of FDA regulations and guidelines, including PMA and 510(k) submissions.
- Excellent communication and project management skills.
- Ability to work independently and as part of a team.
- Strong analytical and problem-solving skills.
Preferred Qualifications:
- Background in cardiovascular solutions or alternative medical implantables, robotics, and/or class III medical electronics.
- Experience with PMA approval and post-market supplements.
- Knowledge of international regulatory requirements.
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