Regulatory Affairs and Quality Specialist
Job Description

One of our clients, who specializes in medical device industry, is looking for a go-getter to add to their Regulatory Affairs and Quality Team.

1) Assist with quality investigations
2) Initiate updates and creation of new functional SOPs as required
3) Serve as a Quality Representative for regulatory inspections as needed
4) Work closely with the QA Manager and Global Quality division
5) Identify efficiency and quality improvements in own area of responsibility and implement required changes
6) Participate in customer and supplier audits
7) Respond quickly and effectively to customer complaints and issues
8) Lead project teams to resolve and permanently fix customer complaints
9) Support the launch of products of biological and chemical nature, providing regulatory assessments and guidance
10) Support the Sales Team with requests (e.g. supplier questionnaires, certificates)
More questions? Want to know the Salary range? Keep reading.

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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



Job Requirements

1) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
2) Recent experience in the medical device industry is strongly preferred
3) Preference will be given to people have recent experience in regulatory affairs/quality

If you imagine yourself working for an excellent company whose employees believe in team work and making great contributions to the industry, this could be a golden opportunity for you.

Company Overview

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.


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