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 #02533 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 Senior Regulatory Affairs Specialist 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 into worldwide regulatory agencies 2) Work with worldwide business partners to recommend strategies for earliest possible approvals of governmental applications 3) Ensure compilation of all material required for worldwide submissions, license renewals and annual registrations 4) Apply scientific principles to understanding safety and efficacy 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 and keeps abreast of global regulatory procedures and changes 7) Provide support to the group by taking on more projects of greater complexity under limited supervision 8) Act as company representative in developing and maintaining positive relationships with worldwide reviewers 9) Address and advise RA Management and teams on appropriate pathways to market 10) Lead investigation and other CAPA team assignments 11) Maintain a professional stature and confidentiality 12) Work to follow all departmental and company policies and standard operating procedures 13) Prepare and submit/support the submission, technical file and design dossiers (i.e. for new and modified medical devices, tissue products and combination products) 14) Interface with worldwide regulatory agencies, notified body, physicians, consultants and internal team members 15) Participate in product development teams to ensure that US and other worldwide regulatory requirements are incorporated as part of the development process 16) Interpret existing and/or new regulatory requirements as per company’s products and procedures 17) Communicate regulatory requirements to appropriate personnel 18) Handle any FDA, International and Industry correspondence on submissions, technical files and design dossiers to appropriate teams and RA management 19) Assist in post market activities 20) Support R&D, Marketing and Operational Teams in regulatory assessment of proposed product changes or product transfers 21) Review product labeling and advertising materials for compliance to US and international regulations 22) Establish and maintain regulatory information systems and label systems both electronically and the hard copy 23) Review and approve change management documentation 24) Prepare and update US and International product listings, registrations, certificates and licenses 25) Participate on CAPA teams 26) Maintain electronic and paper files and documentation to support RA activities 27) RA and QA project and management support as directed Requirements 1) Master’s or an advanced degree in Life Sciences, Nursing, Medical Technology or a related discipline 2) 6+ years of RA or clinical experience (in the medical device, pharmaceutical or life science industries) 3) Hands-on experience in 510(k) submissions and extensive knowledge of FDA and/or international regulations 4) Experience in medical devices and orthopedics a plus 5) Self-motivated with a proactive attitude and the ability to work independently 6) Bilingual preferred (English with Asia Pacific/Spanish) 7) Excellent interpersonal skills (oral and written skills) 8) Experience in sterile and implantable products preferred 9) Ability to react to situations with a ‘sense of urgency’ 10) Excellent organizational skills with emphasis on attention to details
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