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Tangent Medical Technologies, Inc.

General Information

(294659)

Job title: Regulatory Affairs Manager/ Great Benefit Package! Starting Salary $70,000
Job location: Ann Arbor, MI 48103 United States
Requisition code:
Date posted: 08/12/13
Job type: Full-Time
Compensation: Great Benefit Package! Starting Salary $70,000

Job Classification


Job Category:Manager
Regulatory Affairs Specialist

Job Description


Job description:
Assure that Tangent Medical products are developed in line with the global registration requirements of targeted countries and obtains expedient registration of these products in a cost effective manner. Maintain registrations for all products in compliance with applicable regulations. Corporate Management Representative to all agency inquiries.
Major Duties and Responsibilities:
1. Leads the efforts to become certified in ISO 13485 as well as CE mark, CDMAS and others as required
2. Responsible for maintaining a state of compliance to ISO, CE standards as well as regulatory compliance to QSR’s.
3. Develops regulatory strategies for development projects and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities.
4. Manages the preparation of registration packages and responses to deficiency letters. Negotiates submission data requirements and deliverable dates with regulatory authorities and internal technical teams. Author with team members, key pieces of regulatory submissions.
5. Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.
6. Evaluates manufacturing and labeling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
7. Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.
8. Provide managerial support and training to employees by supervising staff, establishing employee goals that align with other business partners, maintaining job descriptions, creating employee development plans, providing performance feedback and recruiting and retaining staff members.
9. FDA liaison on key matters.
10. Submit all types of applications to FDA and other international Regulatory Agencies.
Requirements:
A Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related. Master's degree and/or PhD, preferred. Five to eight years’ experience in the Medical Device industry in Regulatory, R&D, Quality, or similar, with a minimum of three years in regulatory affairs experience and two years with direct supervision experience. Experience working directly with regulatory agencies domestic and international. Thorough understanding of international regulatory requirements for medical device products. Sound knowledge of applicable portions of agency guidance and regulations for medical device products. Ability to challenge scientific arguments. Good oral and written communication skills. Bilingual (English-Spanish) a plus.

Job Requirements


Education, training, experience:
A Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related. Master's degree and/or PhD, preferred. Five to eight years’ experience in the Medical Device industry in Regulatory, R&D, Quality, or similar, with a minimum of three years in regulatory affairs experience and two years with direct supervision experience. Experience working directly with regulatory agencies domestic and international. Thorough understanding of international regulatory requirements for medical device products. Sound knowledge of applicable portions of agency guidance and regulations for medical device products. Ability to challenge scientific arguments. Good oral and written communication skills. Bilingual (English-Spanish) a plus.
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