Regulatory Affairs Manager
This is an opportunity for an ambitious Medical Device Regulatory Affairs professional that wants to use all their experience to be join the New England operations of an established company under the guidance and mentorship of seasoned veterans in the surgical robotics and laser space. With an exciting technology already taking the market by storm, they're looking for your expertise to bring their newer technologies to the world.
Primary Responsibilities :
- Create templates for new regulatory submissions when required and then write, prepare, edit, and review FDA submissions for new product Class II/III submissions.
- Review clinical and analytical protocols and reports for regulatory content.
- Create and maintain regulatory filing repository as required and publish electronic regulatory filings, ship final packages to regulatory agencies.
- Knowledge and ability to advise others on legal or regulatory compliance matters
- Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submissions, and maintenance
- Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources
Knowledge, Skills & Requirements:
- 8 years of related experience and/or training; or equivalent combination of education and experience
- BS degree in a related field of study
- Working knowledge in preparing and submitting 510(k)s.
- Regulatory Affairs Certification is preferred
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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