Partial Job Description
1) Oversee and direct device vigilance programs
2) Interact with subsidiary company and Regulatory functions in NY
3) Ensure that ISO certification program is in place and monitored for the company
4) Develop and implement quality principle and tools
5) Advice project teams on all aspects related to device regulations
6) Act as a quality approver on technical files, 510(k)s, design history documents, product specifications, labelling materials, product registrations
7) Participate in design control throughout a process
8) Act and prepare a management action plan against known gaps
9) Ensure implementation of a plan as per approved timelines
10) Collaborate cross functionally and implement effective solutions
11) Lead quality and regulatory compliance activities as needed
12) Lead business critical projects that impact cross functional departments
13) Lead management review meetings
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TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Healthcare, Life Sciences, Scientist, R&D, Clinical Research, Clinical Trial, Regulatory Affairs, Nutraceutical, Surgeon, MD, Hospital, Immunology, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility, Hospital, Research and Development, Medical Affairs, Drug Safety
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.