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Mgr, Global Regulatory Affairs

Performance Health | Akron OH 44310 USA | Full Time | Posted: 10/15/2019

Job Descriptiontop

The Manager of Global Regulatory Affairs is responsible for implementing global product Regulatory strategies and processes across Performance Health that are focused on ensuring compliant, timely, and cost effective submissions to get needed licenses, registrations, and listings for medical devices and drugs..

To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Job Duties & Responsibilities
Lead Regulatory team in timely execution of submission activities required to secure global market clearances, registrations and licenses for medical device and drug products
Provide leadership to global business in the preparation of regulatory submission documents and activities required to secure global licenses, registrations and listings in a timely and cost effective manner
Develop effective long and short term Regulatory product strategies by closely working with global Sales/Marketing and Product Development teams on pipeline medical device and drug international registrations
Ensure accuracy of Declaration of Conformity for EU in conjunction with Authorize Representative and provide support for medical device and drug classification in global markets
Lead/coordinate the review of product and labeling/claims changes to maintain regulatory compliance
Maintain regulatory records by updating corporate databases, recording and filing appropriate regulatory registrations and submissions
Ensure product labeling and claims are accurate, substantiated, documented, and compliant with applicable regulations
Oversee and maintain site establishment registrations and certifications
Monitor domestic and international regulatory developments changes that may potentially impact the company s products and operations, and provide proactive interpretative analysis of regulations, directives and guidance for required actions
Provide education and training on regulations to company employees, as needed
Investigate and report to global regulatory authorities (as required) product complaints that either have, or may result in serious injury
Performs other duties as assigned

Job Qualifications
BA/BS degree in Pharmaceutical, Life Sciences, Engineering or other related technical field
10 years of Regulatory experience within a medical device/pharmaceutical regulated industry
5 years Regulatory management/supervisory experience
5 years of experience developing and successfully defending complex regulatory submissions for medical devices and drugs
Proven experience building effective relationship with the FDA and other international regulatory bodies including the EU and Health Canada
Experience with submitting Adverse Events/Vigilance reports to applicable global regulatory bodies
Strong knowledge of global country specific regulations required for registering and marketing products for sale in applicable countries
Understanding of FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standards
Ability to travel up to 10% of the time, including overnight travel

Performance Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, and any other characteristic protected by law.

Job Detailstop

Location Akron, OH, 44310, United States
Categories Medical/Health

Location Maptop

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Job Code 305493

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