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Job #03208

About our client Our client is a global leader in processing human bone and connective tissue for relocation and an innovator in developing, manufacturing and marketing biologic, biomaterial and device systems for musculoskeletal surgery. With an exacting focus on spinal, trauma and total joint revision procedures, their current and development-stage technologies address needs within numerous musculoskeletal discipline. Position Location Regulatory Affairs Specialist New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Review product labeling and advertising materials for compliance with US and international law 2) Establish/maintain regulatory information and label systems both electronically and paper 3) Review/approve and modify management documentation when required 4) Prepare/update US and international product listings, registrations, certificates and license renewals 5) Maintain electronic and paper files/documentation to support RA activities, QA project and management support (as directed) 6) Liaise with international business partners to recommend strategies for earliest possible approvals of governmental applications 7) Ensure safety and efficacy of a wide range of products 8) Participate as a regulatory team member on design and investigation projects 9) Monitor control systems and keep abreast of global regulatory procedures/changes 10) Provide support to the group by taking on more projects of greater tasks under limited supervision 11) Lead CAPA teams Requirements 1) Bachelor’s Degree in Engineering or BA/BS in Life Sciences or a related discipline 2) Up to 2 years of experience in RA in the medical device/pharmaceutical/life science industry 3) Excellent interpersonal, communication (written and oral) and organizational skills 4) Project management skills preferred 5) Self-motivated with a proactive attitude and ability to work independently along with attention to detail