Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02534 About our client Our client is in the field of human bone and connective tissue processing for transplants and is a world leader in their field. They are also an innovator in the development, manufacturing, and marketing of biological, biometrical, and device systems for musculoskeletal surgery. The company’s present and development-stage technologies address the needs within many musculoskeletal disciplines. Position Location Regulatory Affairs Specialist – I New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan and coordinate submissions and other document packages for tissue, medical device and combination products with worldwide regulatory agencies 2) Work with worldwide business partners to recommend strategies for earliest possible approvals of governmental applications 3) Ensure compilation of all materials required for worldwide submissions, license renewals and annual registrations 4) Apply scientific principles to understanding safety and efficiency on a wide range of products 5) Participate as regulatory team member on design and investigation projects 6) Monitor and improve tracking and control systems 7) Keep abreast of global regulatory procedures and changes 8) Maintain a professional stature and confidentiality 9) Maintain and follow all departmental and company policies and standard operating procedures 10) Prepare and submit or support the submission, technical file and design dossiers for new and modified medical devices, tissue products and combination products through interface with worldwide regulatory agencies, notified body, physicians, consultants and internal team members 11) Participate with the product development teams to ensure that US and other worldwide regulatory requirements are incorporated as part of the development process 12) Interpret existing and/or new regulatory requirements as they relate to company products and procedures 13) Communicate regulatory requirements to appropriate personnel 14) Communicate with any FDA, international and industry correspondence on submissions, technical files and design dossiers to appropriate teams and RA management 15) Assist in post market activities 16) Support R&D and, Marketing and Operational Teams in regulatory assessment of proposed product changes or product transfers 17) Review product labeling and advertising materials for compliance with US and international regulations 18) Establish and maintain regulatory information systems and label systems (electronically and hard copy) 19) Review and approve change management documentation 20) Prepare and update US and international product listings, registrations, certificates and licenses 21) Participate on CAPA teams 22) Maintain electronic and paper files and documentation to support RA activities 23) Support RA and QA project and management as directed 24) Act as company representative in developing and maintaining positive relationships with worldwide reviewers 25) Address and advise RA Management and other teams 26) Lead Investigation and other CAPA team assignments Requirements 1) Bachelor’s degree in Engineering (or BA/BS in Life Sciences, Nursing, Medical Technology or related discipline) 2) 2+ years of RA or QA experience in the medical device, pharmaceutical or life science industries 3) Experience in sterile and implantable products preferred 4) Medical device and orthopedic experience preferred 5) Self motivated with a proactive attitude and the ability to work independently 6) Bilingual preferred (English with Asia Pacific or Spanish) 7) Excellent interpersonal skills (oral and written) 8) Ability to react to situations with a ‘sense of urgency’ 9) Excellent organizational skills with attention to detail
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