Regulatory Affairs Expert for Medical Devices
3 days ago
We are seeking a highly skilled Medical Device Regulatory Specialist to join our team at Lifelancer. In this role, you will provide direct Worldwide Regulatory support to various projects and products.
About the Job:This is a challenging opportunity to work in the rapidly evolving field of Medical Device Regulation. You will be responsible for providing strategic planning and product development efforts, as well as Regulatory support for existing products with respect to product changes/modifications, labeling, and promotional material review and approval.
Key Responsibilities:- Preparation and submission of Regulatory documents to the FDA and other Regulatory agencies.
- Preparation of responses to FDA questions and other Regulatory correspondence.
- Provision of direct Regulatory support to project teams, including the creation of detailed Regulatory Plans.
- Evaluation of proposed product modifications for Regulatory impact and completion of Regulatory Assessments as needed.
To be successful in this role, you should have excellent knowledge of Medical Device Regulations, including FDA regulations, CE, and ISO standards. Additionally, you should possess good communication skills, both verbal and written, as well as good organizational and analytical thinking skills.
What We Offer:We offer a competitive salary range of $80,000 - $120,000 per year, depending on experience. Our benefits package includes comprehensive health insurance, retirement plan, and paid time off.
About Lifelancer:Lifelancer is a talent-hiring platform that connects professionals with opportunities in Life Sciences, Pharma, and IT. Our mission is to help talented individuals achieve their career goals while making a meaningful impact in the industry.
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