International Regulatory Affairs Specialist

6 days left

Recruiter
Thermo Fisher
Location
Rochester
Salary
Competitive
Posted
27 Jul 2017
Expires
24 Aug 2017
Contract Type
Permanent
Hours
Full Time
Job Description

When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.

Job Description:

Creates, evaluates and supports International regulatory projects consistent with the company goals. Successful candidate is responsible for developing regulatory strategy, assembling regulatory submissions and international dossiers for international partners and supporting/developing international market expansion.

Responsibilities:

  • Oversees select International regulatory projects consistent with the company goals. Ensures timely registration of products in compliance with applicable regulations and guidance.
  • Responsible for the implementation of regulatory strategies through coordination and preparation of submission documents for the registration of new products, changes to existing products and expansion into new international markets (i.e. Canada, EU, Asia, South/Central America, Middle East, Africa and Rest of World) in partnership with International Partners.
  • Author and prepare documentation for International product registrations in responsible regions including; annual reporting, re-licensing, and change reporting.
  • Interact with Regulatory Affairs personnel at regulatory agencies, contract manufacturers and distributors to ensure registrations are current and compliant.
  • Creates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Maintains current knowledge, excellent comprehension and appropriate application of relevant regulations, including proposed and final rules.
  • Communicates any changes in applicable regulations to Senior Manager, Regulatory Affairs and assists with Gap Analysis
  • Requirements:

  • BA/BS degree is required. Preferred education/experience areas include clinical, engineering, physical, biological, and regulatory sciences preferred.
  • A minimum of 3 years of experience with international medical device regulations manufacturing. IVD desired.
  • Previous experience with global regulatory filings (i.e. Canada, EU, Asia and South/Central America)
  • Proficiency in working through third parties to obtain market clearance in other countries
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Excellent organizational skills and ability to support multiple projects
  • Exemplary verbal and written skills
  • Intellectual curiosity and an ability to digest and communicate complex technical data
  • At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

    *IND-LPG



    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.