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Regulatory Affairs Specialist
4 months ago
elliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with the medical community and develop innovative, high quality, cost-effective products benefiting patients, physicians, and medical facilities.
The RA Specialist will be self-directed and motivated and be responsible for preparing global regulatory submissions and obtaining and maintaining approvals necessary to market products world-wide.
Essential duties & responsibilities:
Ensure compliance to FDA and global requirements, i.e. ISO, CE, EU, CFDA, etc., and corporate policies and procedures for market approval of medical devices,
Prepare documentation for global submissions and ensure existing approvals and documentation are maintained.
Communicate with in-country RA personnel to facilitate clearances/approvals.
Prepare Certificates to Foreign Governments
Review and approve labeling for compliance to standards, guidelines, regulations, and regulatory clearances/approvals.
Qualifications:
Bachelor’s Degree with 4 yrs of related regulatory experience is required
Regulatory Affairs Certification (RAC) a plus
Familiarity with International Medical Device registration requirements (Canada, Europe, China, Japan, Brazil, Russia, etc.)
510(k), IDE, PMA, CE Technical File preparation, review and submission experience.
Knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD), and applicable guidance documents.
Candidates within commuting distance of our offices in Baldwin, LI, NY, or Boca Raton, FL, are desired. Remote candidates will be considered.
Salary commensurate with experience
As a global company, elliquence educates physicians on the least invasive procedural solutions for spine pathology and provides our unique and specialized tools to support these procedures. The procedures are truly the least invasive solutions available today, and generally begin with targeting the spinal anatomy with a spine needle. Our tag line, “Less is More” is the absolute truth.
What we offer:
Base salary and annual performance-based bonus.
Medical, dental, vision and life insurance
401(k)
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