The Senior Regulatory Affairs Specialist will be responsible for supporting international and US regulatory submissions.
We have several locations available for this role: NJ, NY, MA, CA, UT, TX, FL, MD, and NC.
- Compile, prepare, review and submit regulatory submissions to FDA and international authorities.
- Write and edit technical documents to support regulatory submissions.
- Assist in the development of regulatory strategy and update strategy based on regulatory changes.
- Provide regulatory input to product lifecycle planning.
- Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval.
- Participate in risk-benefit analysis for regulatory compliance.
- Assist in SOP development and review.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
- Assess acceptability of quality, preclinical and clinical documentation for submissions to comply with regulatory requirements for clinical trials and marketing applications.
- Monitor impact of changing regulations on submission strategies.
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
- Create project plans and timelines.
- Bachelor’s degree in a scientific or related discipline is highly preferred. Or, equivalent combination of education and experience.
- Minimum of 5-10 years regulatory affairs experience in a medical device company working with Class II/III medical devices or submissions requiring randomized clinical trials.
- Experience working with FDA and/or international agencies.
- Ability to work effectively in cross-functional team.