Senior Regulatory Affairs Specialist

College degree or equivalent work experience in Regulatory, Quality or R&D.
Minimum of 5 years experience in Regulatory Affairs.
Experience with FDA QSR requirements, ISO 13485, and EU Medical Device Directive regulatory requirements.
Excellent oral and written communication skills.
Public speaking proficiency.
Willing to mentor others.
Ability to prioritize, conduct team meetings, and meet project deadlines.

Prepare domestic and international product submission and reports including: U.S. FDA 510(k)s, IDEs, PMAs, annual reports, international product registrations, MDRs, Vigilance Reports and Problem Reports.
Prepare Technical Files.
Prepare and review product labeling.
Prepare correction and removal (recall) reports and coordinate recall related activities.
Provide regulatory affairs support to project teams.
Develop regulatory strategies for new products.
Review design changes and assess regulatory implication relative to the design change.
Provide regulatory support for quality system related changes i.e. ECOs, MCOs, NCMRs, SDRs, etc.
Help drive process and compliance improvements activities.
Lead health hazard evaluations to determine risk associated with post-market product issues.
Provide regulatory affairs support during external inspections (FDA, BSI, etc.).
Provide regulatory affairs guidance to other Orthofix departments, as necessary.
Regular attendance required.