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SENIOR REGULATORY AFFAIRS ASSOCIATE
LOCATION: WARWICK, RI
Scope of the Job:
The position of Senior Regulatory Affairs Associate is located in Warwick, RI and will report to the Vice President, Regulatory and Quality. You will be responsible for providing technical and administrative direction to ensure the timely introduction of new products subject to medical products regulations. You will also provide regulatory support to marketed products.
Responsibilities Include:
Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)'s, IDE's, PMA's)
Assist in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed.
Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
Prepare applications for international marketing approvals (i.e. CE Mark Technical files and Dossiers).
Assist Product Development and Quality Assurance in planning animal studies and bench testing that will ultimately be used in regulatory submissions.
Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies.
Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
Candidate Profile and Requirements:
B.S. degree or equivalent with emphasis on Life Sciences. Professional certifications preferred.
Knowledge and experience 3-5 years with regulatory requirements for medical devices including submission of IDE's, PMA's and 510(k)'s, and CE mark technical files.
Good oral and written communications skills and ability to work on cross-functional teams.
Working knowledge of statistics and electronic documentation and information systems.
Ability and desire to travel as needed.
Compensation:
A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus and an attractive benefits package.
Send Resume and Cover Letter to:
Tracy Wolfe
Phone: 512 327-7277
Phone: 512-327-7275 · Fax: 512-327-1774
E-mail: search@pprecruiters.com · Website: www.pprecruiters.com
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