Regulatory Affairs Associate

This candidate will be responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

Reliable attendance is required for this position. Must be able to function independently in a leadership role, but also able to recognize when management consultation or approval is required. 4 years of experience in a medical device or other FDA-regulated industry; Quality Assurance experience preferred * Knowledge of medical device Quality System Regulations (21 CFR 820, ISO 9001/13485) * Familiarity with MS Office applications - Outlook, Word, Excel, Power Point * Ability to conduct internet research * Detail-oriented * Ability to work in team environment * Excellent written and verbal communication skills (writing samples may be requested)

Please contact me if you think you or someone you know would be a good fit for this role.
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