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The Regulatory Affairs Staff Specialist is responsible for US regulatory submission strategies, drafting & reviewing submission documents, interacting with other individuals within the US Market Access department, development counterparts, as well as with regulatory bodies to facilitate timely and successful product clearances. Experience in the hands-on preparation of 510(k) submissions for In Vitro Diagnostic products required. Face-to-face meetings with regulators will be considered as a valuable asset (e.g. Pre-Submission meetings, submission issue meetings, etc.). Experience in working with regulatory consultants and contract research organizations is a plus.
- Base salary $80K – $90K Depending on experience (plus annual bonus)
- Fully paid family medical
- Life Insurance
- Vacation, PTO, and paid holidays
- Tuition Reimbursement
- Bachelor’s Degree in a scientific or engineering discipline plus 5 or more years relevant experience in Regulatory Affairs in the area of In Vitro Diagnostics
- Active participation in regulatory industry associations is a plus
- RAC registration preferred.
- Prior Diagnostics experience is required.
- Up to 30% Travel (International and Domestic) may be required depending on project demands.