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Director, Regulatory Affairs CMC Medical Device and Combination Products

Merck


Location:
NJ-Kenilworth, NJ
Date:
08/16/2017
2017-08-162017-09-15
Job Code:
REG002917
Merck
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Job Details

Job Title: Director, Regulatory Affairs CMC Medical Device and Combination Products  - REG002917

Description
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck’s Regulatory Affairs organization helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time. 

The Director, Regulatory CMC, Devices and Combination Products responsibilities include, but are not limited to the following:
  • This position will lead development of regulatory strategy and execute 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. 
  • 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 maintained 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 issues 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.
  • Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance, medical devices). 
  • Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. 
  • Demonstrated effective leadership, communication, and interpersonal skills. 


Qualifications
Education:  
  • Bachelor's Degree in pharmacy, chemistry, engineering or a related discipline with a minimum 15 years of CMC/regulatory affairs experience in small molecules, biologics, vaccines, medical devices and/or combination products OR a post-graduate degree with a minimum of 10 years of CMC/regulatory affairs experience in small molecules, biologics, vaccines, medical devices and/or combination products
Required:  
  • Minimum 5 years regulatory CMC experience with 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.
Preferred:  
  • Strong knowledge in regulatory guidances and expectations for Combination Products
  • Knowledge of Medical Device Mobile Apps 

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

If you need an accommodation for the application process please email us at staffingaadar@merck.com

Search Firm Representatives Please Read Carefully:  
Merck is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

For more information about personal rights under Equal Employment Opportunity, visit:




HJ72017



Job Regulatory Affairs - CMC

Primary Location NA-US-NJ-Kenilworth

Other Locations 

Employee Status Regular

Number Of Openings 1

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