1. Home
  2. About
  3. Manufacturing Engineering

Principle Regulatory Affairs Specialist

Principle Regulatory Affairs Specialist

Principle Regulatory Affairs Specialist - Shannon or Galway

Are you looking for step up n your career, I have a great opportunity available in Shannon to support a Global Healthcare leader in Orthopedic Medical Devices.

This person will have accountability for managing all facets of Regulatory Affairs taking products to market, including submissions, projects, labeling, and acting as SME on all reg affairs matters.

What you will need:

  • Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers,
  • Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail
  • Ability to manage competing priorities;
  • Advanced knowledge of overall medical device business environment, with knowledge of orthopedic industry and products being advantages
  • Demonstrated strong knowledge of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices, as applicable
  • Ability to function well as a member of the team and team leader, as well as build relationships between RA and other areas of the organization
  • Ability to identify and assess business risks to develop Regulatory strategy
  • Ability to handle increasing levels of responsibility
  • Ability to build and lead a strong RA team; ability to lead and influence others
  • Ability to negotiate with regulatory agencies, management, and other groups as necessary
  • Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU as applicable

 

Education/ Experience Requirements

 

  •  Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
  • 6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU
  • A minimum of 3 years of experience in medical device, drugs, biologics, and/or combination products, preferred
  • Regulatory Affairs Certification (US or EU) preferred
  • A combination of education, experience, leadership, strategy and RA influence may be considered

Skills:

regulatory affairs, medical devices, FDA, EUMDR