Director of Regulatory Affairs
1) Develop strategies for regulatory approval and introduction of new products to market
2) Manage the process from development of regulatory strategies through to approval
3) Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval
4) Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards
5) Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements
6) Establish appropriate risk analysis activities which include the use of risk analysis tools
7) Establish solutions to regulatory problems utilizing novel approaches when required
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people have recent experience in regulatory affairs management
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.