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Regulatory Affairs Manager

Location: PA
Industry: Medical Device
Job Code: 12024-05

Responsibilities:

- Prepares, reviews and submits necessary regulatory information to FDA to obtain 510(k) clearance and PMA approval of products.
- Coordinates with various functional areas in the preparation, review and submission of IDE applications for clinical studies, as well as other clinical studies.
- Reviews all submissions to FDA and international agencies for completeness, truthfulness and compliance with regulations.
- Serves as the primary contact to FDA for review of submissions to FDA.
- Keeps up-to-date on proposed regulations and guidelines published by FDA and international agencies.
- Reviews advertising and promotional material and device labeling for regulatory compliance.
- Controls the introduction of product through the United States market through management of the release approval process.
- Initiates changes to practices and procedures to support compliance requirements
- Brings regulatory compliance questions/issues to the attention of senior management
- Provides general guidance or training support of professional staff.
- Provides interpretations & direction to applicable company personnel regarding the regulatory aspects associated with relevant functions.

Requirements:

• 10-15 years of successful experience in related field and successful demonstration of increasing responsibility and accomplishment in the responsibilities described above.
- Experience in the medical device industry preferred, but relevant experience in the area of combination products (drug/devices) will be considered.
- Demonstrated excellent writing skills in the preparation of technical documents based on technical reports prepared by other technical functions.
- A thorough understanding of U.S. FDA regulatory laws and requirements to ensure compliance to regulations without hindering business and growth and understanding of regulatory laws in major international markets.
- High levels of professionalism, ethics and compliance in order to interact with FDA and serve as a representative of company.
- Strong written and oral communication skills in order to facilitate communications with FDA and minimize FDA inquiries.
- Advanced degree may be substituted for experience, where applicable.

Contact:

For more information on this or any of our other available positions or to be contacted by one of our staffing specialists, please send us your resume, cover letter and RegExec job code to resume@regexec.com.

PLEASE NOTE: All resumes that are received by RegExec will be thoroughly reviewed by one of our staffing specialists and treated confidentially.