Sr. International Regulatory Affairs Specialist Job at Custom Search Inc., Minneapolis, MN

c1VFUzZpQ3lmbXNUbkRpdmF2dExmY211
  • Custom Search Inc.
  • Minneapolis, MN

Job Description

Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team! The Sr. Regulatory Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Sr. Regulatory Affairs Specialist will perform regulatory submission/approval activities for all products and ensures compliance with required regulations and established corporate standards.

Your role with the company:

  • Preparing documentation for international regulatory registrations
  • Preparing technical documentation compliant with regulations
  • Defining worldwide regulatory requirements necessary for regulatory approval of products
  • Participating on cross-functional teams as regulatory lead
  • Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages
  • Authoring submissions, researching requirements, setting priorities, and maintaining project schedules
  • Providing guidance and oversight to team members related to regulatory compliance
  • Act as a Subject Matter Expert (SME) to support internal and external audits

Desired Profile:

  • Bachelor’s Degree in Science, Engineering, or other relevant discipline
  • Minimum 8 years’ experience in Regulatory Affairs in the medical device industry
  • FDA, EU, Health Canada, and international registrations experience
  • Working knowledge of quality system regulations and guidelines
  • Ability to develop clear, concise, and timely oral and written reports
  • Great communication skills with all levels of personnel
  • High level of organization and planning skills
  • Working knowledge of medical devices, procedures, and terminology

Job Tags

Remote job, Worldwide,

Similar Jobs

Legacy Health

RN Staff Nurse - Pediatric Unit 8th floor Job at Legacy Health

 ...and elementary age med/surg patients ages 7-13. Responsibilities Responsible for patient care within an assigned department/unit and participates as a member of the health care team in cooperation with and under the direction of the clinical manager or designee... 

Vistage Worldwide, Inc.

Vistage Executive Coach Job at Vistage Worldwide, Inc.

 ...Join the Premier CEO Coaching Community as a Vistage Chair Are you ready to lead a CEO coaching business in the Washington, D.C. area,...  ...Sustained Income: Enjoy a revenue stream that can continue well into retirement. Flexible Schedule: Design a schedule that suits... 

Austin Fleet Services

Diesel Mechanic (Truck & Trailer) Job at Austin Fleet Services

 ...Experienced Diesel Mechanic (Truck &Trailer) Needed Austin Fleet Services (AFS) is hiring for an experienced diesel mechanic to add to our growing business ! We are a mobile and in-shop fleet maintenance and repair company serving customers in Texas. Why join Austin... 

LuckyGunner.com

Bookkeeper Job at LuckyGunner.com

 ...content. Who we need : We are looking for an experienced bookkeeper to join our accounting team on a part-time basis. We arent...  ...experience working in accounting or bookkeeping Proficient in QuickBooks Online Advanced Excel skills Strong understanding of... 

FOCO

Marketing Associate - Paid Search, Growth Marketing Job at FOCO

 ...Marketing will be responsible for developing and implementing digital marketing campaigns across various channels, including social media, PPC advertising, and search engine optimization (SEO). As Paid Media specialist you will be responsible for implementing FOCOs Paid...