RA Manager

ESSENTIAL FUNCTIONS:§ Manage, direct, control, maintain and update regulatory requirements for both medical devices and pharmaceuticals with a focus on results and compliance. Liaison with appropriate regulatory control agencies.§ Create and maintain appropriate registrations for interstate commerce of medical devices and drugs§ Create and maintain appropriate registrations as a Connecticut healthcare manufacturer§ Perform duties as Person Responsible for Regulatory Compliance (PRRC)§ Management representative designee for all regulatory purposes.§ Provide input so that Quality System maintains compliance to MDSAP, EU MDR and other regulatory obligations§ Participate as member of design team for regulatory and risk assessment activities§ Participate as member of internal audit team for regulatory and risk assessment activities§ Participate as required for external or customer audits§ Create and maintain Device Master Records, Medical Device File and Technical Files§ Assists or leads in quarterly management review of the Quality System§ Assists in creation and maintenance of customer or supplier QA/RA contracts§ Assists in review of all change notice requests§ Assists in review of Approved Label Copy documents§ Assists/Coordinates in any MDR/Adverse Event, Recall or Field Safety Notice activities§ Maintains External Standards database§ Other duties as required.§QUALIFICATIONS, SKILLS, ABILITIES REQUIRED:§ Results oriented with the goal of achieving product registrations in a timely fashion consistent with Marketing launch plans§ Ability to lead or coordinate for interdepartmental regulatory projects§ Excellent planning, organizational, and time management skills§ Excellent people skills, with the ability to communicate well with all levels of both management and non-management personnel§ Good understanding and familiarity of MDSAP and ISO 13485:2016 requirements§ Good understanding and familiarity with:· FDA: Establishment Registration & Device Listing, CFG’s, UDI· EU: MDD & MDR, Technical Files· Canada: Establishment Registration & Device Licensing· Australia, Japan or other Rest of The World (ROTW) practicesEDUCATION, EXPERIENCE REQUIRED:§ Bachelor’s degree in Engineering, Biology, or Chemistry required§ Minimum of 5 years’ experience with similar regulatory responsibilities§ Auditing experience a plus§ Management Representative experience a plus§ FDA 510(k) processing experience a plus§ Natural Health Product regulatory experience a plus§ US/EU Cosmetic regulatory experience a plus§ US/EU Rx/OTC Drug regulatory experience a plus§ RAPS membership/accreditation a plusTRAINING REQUIRED:§ cGMP Training§ E-DOC Network§ FDA, CGMPs, MDD. MDSAP§ Job Specific Procedural Training§ Quality Manual§ Safety Policy§ SOP-010 Emergency Action§ SOP-011 Hazcom§ SOP-014 Personal Health and Cleanliness§ SOP-018 Training§ SOP-039 EU Regulatory Compliance§ SOP-041 Canadian Regulatory Compliance§ SOP-042 FDA Device Regulatory Compliance§ SOP-043 Japanese Regulatory Compliance§ SOP-044 Brazilian Regulatory Compliance§ SOP-045 Australian Regulatory ComplianceSDL2017