Director, Regulatory Affairs
Develop and execute sound regulatory strategies for a range of complex existing products and new product development programs, with emphasis on regulatory requirements and submissions associated FDA Class II and Class III devices including combination products.
- Acts as an internal expert of regulatory requirements of all major markets globally and maintains good working relationships with regulatory agencies.
- Provides a strong understanding of the new European Medical Device Regulations (MDR).
- Demonstrates strong understanding of drug-device combination products and products with animal origin materials.
- Monitors industry and regulatory trends and develop strategy and provide guidance related to such trends.
- Provides a leadership to the regulatory team and cross-functional teams on multiple product lines during product development, regulatory submissions and post-market issues with an effective and efficient regulatory strategy.
- Coordinates company activities to ensure the timely submission and approval of applications, amendments, supplements, and other regulatory correspondence.
- Develops and maintains documents for a regulatory submissions to US FDA, EU notified body and other regulatory agencies
- Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status.
- Ensures timely facility registration, device listing, periodic reports etc. per U.S. FDA requirements and the requirements of foreign markets.
- Sets, interprets, executes and recommends modification to internal guidelines, work instructions, and procedures related to regulatory affairs.
- Tracks the status of regulatory submissions during submission development and review/approval progress and communicates to management.
- Bachelor’s degree in life science or engineering. Masters and or PhD is preferred.
- Minimum 7 years of medical device regulatory affairs experience with USFDA and international regulations and submissions. Minimum 3 years of experience in a leadership role with supervisory responsibilities is required.
- Ability to work independently and as part of a team.
- Demonstrated leadership and team building skills.
- Ability to work with minimal supervision on multiple concurrent tasks/activities and meet corporate strategies and goals.
- Excellent computer skills, knowledge of Microsoft Office package, Windows and e-mail systems.
- Excellent verbal and written communication skills and the ability to work with all levels within the Company, international distributors, and regulatory agencies.
- Strong organizational skills and attention to detail.
- Experience with sterile disposable device submissions, drug-device combination product submissions
EQUAL OPPORTUNITY EMPLOYER – DISABILITY AND VETERAN
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Job posted: 2020-09-16