Careers at ExThera Medical
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Director Clinical and Regulatory Affairs
The Director Clinical and Regulatory Affairs develops regulatory and compliance policies to meet requirements of global, federal, state, and local governments for company products. Ensures the appropriate regulatory, licensing, marketing and legal compliance of ExThera Medical products in order to control the safety and efficacy of the products. Advises on, coordinates, and drives the approval and registration of ExThera Medical products.
- Official correspondent for FDA, OUS, and notified bodies.
- Co-write, review, and edit regulatory submissions, obtaining cross-functional input as needed. Format, publish, and submit documentation in accordance with requirements and regulatory guidance. (Pre-Submission, Risk Determination, 510(k), DeNovo, Tech Files, etc.).
- Review and advise applicable global, federal, state and local government regulations of selling medical products.
- Ensures that ExThera Medical products comply with the regulations of the FDA, MDD, and any other regulatory body necessary.
- Writes, trains, and enforces policies required by global, federal, state and local government regulations on the manufacture and sale of medical devices.
- Directs and co-authors regulatory submissions as per US and International regulations.
- Works with ExThera Medical compliance, quality, regulatory, marketing, and outside counsel to ensure compliance with local, state, federal and global regulations.
- Develops compliance plan with remediation for non-compliance.
- Review and determine applicable global, federal, state and local government regulations of working with clinicians such as the Sun Shine Law (Open Payment).
- Leads Sun Shine Law submissions to CMS to ensure ExThera Medical compliance.
- Keep abreast of international legislation, guidelines and customer practices in all countries that ExThera Medical exports.
- Write clear, accessible product labels and patient information brochures.
- Advise public relations firm on regulatory requirements in the content of company publications
- Plan and develop clinical trials and interpret trial data.
- Communicate effectively with IRB’s, and clinicians to maintain submission goals.
- Represent ExThera Medical as Clinical Site Monitor.
- Advise ExThera Medical Team Members on regulatory requirements.
- Provide strategic advice to Leadership Team throughout the development of new products.
- Undertake and manage regulatory inspections.
- Review company practices and providing advice on changes to systems.
- Liaison with, and make presentations to regulatory authorities and negotiate for marketing authorization.
- Negotiating with regulatory authorities for marketing authorization.
- Specifying storage, labeling and packaging requirements.
- Work with Leadership Team to develop the yearly strategic plan.
- Minimum Bachelors of Science or BA degree in life sciences or equivalent. Engineering or similar degree is a plus.
- Minimum 5 years of experience in Regulatory Affairs in the medical device industry. International experience is a plus.
- Must understand medical device requirements including QSR, ISO13485, ISO14971
- Having experience in a start-up or small company environment is a plus
- Have had close involvement in at least one complete medical device product development cycle from product development through marketed product
- Have experience in submitting medical device reports
- Proven ability to prepare device applications (i.e. IDEs, 510(s), Technical Files, etc).
- Ability to review and conduct gap analysis against new FDA guidance or OUS requirements.
- Ability to travel