Description
Experience:
- Minimum 15 years professional experience in the applicable role.
Education:
- Bachelor's/Master's/may require an M.D. or D.O.or equivalent combination of education and experience. Expert and technical lead with proven experience. May require licensure and certifications in the area of specialization.
Description:
- Plays a pivotal role in overseeing the quality and scientific integrity of studies, may be involved in all steps of the clinical research protocols and work with the team to perform required procedures of studies, supports regulatory compliance performing the required activities that assure compliance with FDA regulations for class III products.
- Is a subject matter expert in Clinical and or Regulatory Affairs, evolving regulatory landscape. May handle or support regulatory requests from regulatory agencies, prepare and/or review submissions to FDA and other regulatory bodies, maintain registrations and device listings, support the reporting of departmental metrics, support and backup for other Q&R functions, supports internal/external audits and regulatory inspections.
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. to ensure the regulatory strategy is in alignment with company objectives.