Regulatory Affairs Manager
Partial Job Description
1) Compile domestic and international regulatory submissions for product approvals
2) Interact with regulatory bodies for submissions (medical device or pharma)
3) Manage international regulatory requirements (medical device inspections, inquiries) of ISO 13485, EU
4) Accomplish quality system/GMP requirements (medical device or pharma)
5) Manage labeling requirements (medical device/pharma) directives
6) Oversee technical/scientific methodology and data review for compliance and submissions
7) Review QC product, product complaints/adverse event investigation data
More questions? Want to know the Salary range? Keep reading.
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Qualifications / Skills Required
1) Advance degree in sciences (MS, PhD) preferred
2) Education and experience in release/shelf-life data
3) Minimum 4 - 10 years of related experience and/or training or equivalent combination of education
4) Supervisory experience
5) Background in a scientific discipline along with experience
7) Proven team management skills
8) Demonstrated communication (written/oral) skills
9) Dispute resolution skills
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.