Title: Principal/ Sr. Regulatory Affairs Specialist
A novel bioelectric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. Company has developed the first commercial product to harness the distinctive advantages of the Company's proprietary Nano-Pulse Stimulation (NPS) technology to treat a variety of applications for which an optimal solution remains unfulfilled.
The Principal or Senior Regulatory Affairs Specialist will be responsible for regulatory activities related to the development and implementation of regulatory strategies to support the submission and filing of multiple indications in Dermatology, General/Plastics and Oncology for electrical surgical medical device products in the US. This role provides leadership within cross-functional project teams and execution of regulatory deliverables and submissions. In addition, this position will require direct and hands on experience to support the development and implementation of FDA QSR and ISO 13485: 2016 QMS and applicable regulatory compliance activities.
- Develop and implement competitive and effective FDA regulatory strategies for various Dermatology, General/Plastics and Oncology products and identify potential risks associated with proposed strategies.
- Manage and participate in the creation, review, editing, assembly and submission of regulatory documentation such as 510(k)s, Pre-subs, Letter-to-Files, IDEs, and PMAs. Responsible for implementation and operations for regulatory submissions, progress reports, supplements, amendments, or periodic reports.
- Interacts with regulatory agencies to expedite submissions and/or approval of pending regulatory reviews.
- Monitors regulatory outcomes of initial product concepts and provide input to senior regulatory management.
- Reviews preclinical and clinical study documents and reports for regulatory submissions.
- Serves as regulatory liaison throughout product development lifecycle.
- Bachelor's degree in a life sciences, engineering, or related discipline.
- 4 to 10 years of experience in Regulatory Affairs in the medical device industry including an in-depth knowledge and understanding of the FDA regulatory environment.
- Solid understanding and proving practices within both FDA QSR regulations and ISO 13485: 2016 quality system management.
- Experience with both high risk device and low risk medical devices (Class III/II/I).
- Experience with clinical and indication expansion submissions is a plus.
- Dermatology (aesthetics), General/Plastics Surgery or Oncology or electrical surgical devices experience preferred.
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