Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Associate Director, Regulatory CMC, Devices and Combination Products duties and responsibilities include, but are not limited to the following:
- Leads development of regulatory strategy and executes the preparation, maintenance of chemistry, manufacturing and controls (CMC) sections of regulatory submissions and responses to agency questions for worldwide registration for the assigned medical device or device aspect of combination products (pharmaceutical, biologics or vaccine (with medical devices)). Regulatory submissions are global and include Investigational New Drug applications, 510(k) clearances, Worldwide Marketing Applications and maintenance of marketed products (post approval submissions and renewals), as well as associated responses to agency questions for medical devices and the medical device aspect of combination products.
- Assures that filed information is kept current following applicable departmental procedures/tools and databases and maintains appropriate documentation to maintain CE marked products within regulatory compliance. Serves as a medical device and combination product Subject Matter Expert to drug product CMC experts in product development and marketed product teams.
- Develops and maintains expert knowledge of current global regulatory CMC requirements for medical devices and combination products for initial clearance, registration, re-registration and post-approval changes. Provides scientific and regulatory guidance to Regulatory CMC experts during development and for marketed products and assures that the information available will meet regulatory expectations for intended countries. Identifies and resolves technical and operational problems associated with regulatory strategy and submissions; collaborates with peers to resolve cross-functional obstacles.
- Looks for innovative and scientifically sound approaches to gain approval and clearance of medical devices and associated products. Participates in the development of business processes associated with the CMC aspects of medical devices and combination products. Represents Merck at FDA project-specific meetings as well as industry meetings.
- Required: Bachelor's Degree in pharmacy, chemistry, engineering or a related discipline
- Preferred: Post-graduate degree
- Minimum 3 years regulatory CMC experience with medical devices and/or combination products
- Minimum 7 years of CMC/regulatory affairs experience in small molecules, biologics, vaccines, medical devices and/or combination products.
- Strong oral and written communication skills
- Effective problem solving and decision making skills
- Innovative, flexible and collaborative with demonstrated leadership skills.
- Strong knowledge in regulatory guidances and expectations for Combination Products
- Knowledge of Medical Device Mobile Apps
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com. Search Firm Representatives Please Read Carefully:
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