Manager/Director Regulatory Affairs and Corporate Compliance – Carlsbad, CA

JOB SUMMARY: This person is responsible for regulatory submissions to FDA and international agencies for medical device clearance, approval and/or licensing as well as for clinical studies related to device. Works closely with others to prepare submissions for new products and product changes as required to ensure timely approval for market release. Interfaces with multiple functional areas, geographies and divisions within the company. This person will serve as the Corporate Compliance Officer.

ESSENTIAL DUTIES AND 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 including marketing 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 and corporate 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.
Acts as Corporate Compliance Officer to review, audit and ensure compliance with corporate compliance policies and procedures.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

Minimum of BS/BA in scientific or engineering discipline or equivalent combination of education and experience. MS or JD preferred.
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 Heidelberg Engineering.
Strong written and oral communication skills in order to facilitate communications with FDA and minimize unnecessary FDA inquiries.
Advanced degree may be substituted for experience, where applicable.
Approximately 20% of time may require domestic and/or international travel.
German language ability strongly preferred.

Heidelberg Engineering, Inc.
1808 Aston Ave., Suite 130
Carlsbad, CA 92008
800-931-2230

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