Regulatory Affairs Specialist (Tarrytown, NY)
The Regulatory Specialist will assist the company to meet its regulatory responsibilities associated with the marketing of its medical device and medicinal products in Europe, Canada, Australia and other International markets. These responsibilities include requirements to:
Assess compliance of various medical devices with the “Essential Requirements”.
- Review and approve device IFUs and product labels.
- Classify devices under the appropriate rules for classification.
- Generate and sign Declarations of Conformity.
- Generate product Technical Files.
- Compile CTD documentation
- Assess products for any risks to patients from a toxicological, clinical. microbiological or manufacturing perspective and completing Risk Analyses to meet the requirements of ISO14971. (20%)
- To assess biocompatibility and compliance with ISO10993 (10%)
- -Critically evaluate clinical data by literature review and update the evaluation as appropriate with the PMCF (post market clinical follow up) report. (10%)
- Review and approve device IFUs and product labels. (20%)
- Keep abreast of regulatory developments, guidelines and regulations, including MEDDEV, GHTF and IMDRF guidelines, and proactively generate Gap Analyses to determine how the changes affect the Company (10%)
- Ensure all components of the Technical files are maintained up to date and reviewed on a regular basis. (5%)
- Review all changes for their impact on the Risk Analysis (5%)
- Liaise with the European Authorised Representative and the European in-country marketing staff as appropriate (5%)
- Compile CTD documentation or assemble in formats dictated by the market (15%)
- Bachelor's Degree in Scientific or health related field.
- Knowledge of medical device regulatory requirements
- A degree of clinical knowledge (particularly dental)
- To have toxicological understanding, particularly of polymers
- Relevant microbiological knowledge including disinfection and preservative efficacy
- Experience and ability to undertake the main responsibilities of the job
- 2+ years of experience in medical device Regulatory Affairs
Prestige-Tarrytown enjoys a HYBRID work week. In this role, you will work in the Tarrytown Office on Tuesday, Wednesday and Thursday and on Mondays and Fridays you may work from home for a total of 40+ hour work week.
SPONSORSHIP: NOT AVAILABLE for this role.
RELOCATION: NOT AVAILABLE for this role.
Prestige is an Equal Opportunity Employer
Search Firm Representatives - Please read carefully:
PRESTIGE CONSUMER HEALTHCARE does not accept unsolicited assistance from search firms. Please, no phone calls or emails. All resumes sent by search firms to any employee at Prestige Consumer Healthcare via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Prestige Consumer Healthcare. No fee will be paid in the event the candidate is hired by Prestige Consumer Healthcare as a result of the referral or through other means. Thank you for your cooperation.