We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team:
1) Develop new products, line extensions and change through the design control process
2) Provide clearance or approval through the FDA 510(k) or PMA process, including IDE submissions and modular PMAs
3) Prepare regulatory strategy/plans and requirements
4) Participate in the review and disposition of labeling, promotional material and product modifications
5) Prepare documentation and coordinate activities related to PMAs, 510ks and IDEs
6) Support engineering changes through RA/QA practices by documenting the changes in compliance with the quality systems regulations
7) Participate in cross-functional departmental team projects and products development activities/meetings
8) Provide interface between regulatory agencies such as the Food and Drug Administration (FDA) and the European Notified Body
9) Ensure for FDA/ISO/MDD/CMDR compliance documentation
10) Assist in special projects as needed
11) Contribute to team effort by accomplishing related duties as requested
More questions? Want to know the Salary range? Keep reading.
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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 who have recent experience in regulator affairs
This is an amazing opportunity for someone who isn't afraid of rolling up their sleeves to get things done and has a great attitude. Our client believes in adding value to each and every thing they do and are looking for someone with similar values.
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.