Regulatory Affairs Professional
1 day ago
We are seeking a highly skilled Regulatory Affairs Specialist to provide direct Worldwide Regulatory support to various projects and products. This role will involve strategic planning, product development efforts, and Regulatory support for existing products with respect to product changes/modifications, labeling, and promotional material review and approval.
The ideal candidate should have knowledge of Medical Device Regulatory, FDA regulations, CE and ISO, etc. They must possess excellent communication skills, both verbal and written, as well as good organizational skills and analytical thinking, problem-solving, and investigative skills.
- $90,000 - $120,000 per year salary range (depending on experience)
In this role, you will be responsible for writing, coordinating, and completing the submission of Regulatory documents to the FDA and other Regulatory agencies (e.g., EPA). You will also prepare responses to FDA questions and other Regulatory correspondence, provide direct Regulatory support to project teams, and conduct product labeling and advertising review and approvals.
- Expected Experience: 1-3 years in Regulatory Affairs or related field
- Required Skills:
- Knowledge of Medical Device Regulatory, FDA regulations, CE and ISO, etc.
- Excellent communication skills, both verbal and written.
- Good organizational skills.
- Good analytical thinking, problem-solving, and investigative skills
Lifelancer Benefits:
- A competitive salary range ($90,000 - $120,000 per year)
- A comprehensive benefits package
- Ongoing training and professional development opportunities
Job Responsibilities:
- Writes, coordinates, and completes the submission of Regulatory documents to the FDA and other Regulatory agencies (e.g., EPA).
- Prepares responses to FDA questions and other Regulatory correspondence.
- Provides direct Regulatory support to project teams including the creation of detailed Regulatory Plans.
- Conducts product labeling and advertising review and approvals.
- Evaluates proposed product modifications for Regulatory impact. Completes Regulatory Assessments as needed.
- Subject Matter Expert on medical device-specific regulatory affairs.
- Liaison between client Program engagement manager and Hops Healthcare delivery execution team for assigned projects.
This is an exciting opportunity to join Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT.
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