Senior Regulatory Affairs Specialist

Recruiter
HERO Recruitment
Employment Type
Contract
Salary
Not disclosed
HERO Recruitment logo

Senior Regulatory Affairs Specialist
12 month Fixed Term Contract
Galway & Remote

Working in Regulatory Affairs is in big demand right now. We’re looking to speak with experienced Senior Regulatory Affairs professionals who are looking to work with top global leaders who value their people. This is a great job opportunity in Galway with remote work an option for a Senior Regulatory Affairs Specialist who enjoys working on innovative projects, values autonomy in their job and working in a great team. Talk with us about this newly created job opportunity to find out more.

Key Responsibilities

  • Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.
    Takes ownership for regulatory decisions impacting projects/ changes, and defends those decisions to other functions/ regulatory agencies based on sound regulatory knowledge
  • Provides strategic thinking to achieve desired regulatory objectives.
  • Provide technical review of information to support regulatory submissions/ product files to assure accuracy, clarity of presentation and compliance with applicable laws, regulations, or standards.
  • Ability to recognize and communicate risk.
  • Interfaces with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
  • Review and update of EU Technical Documentation.
  • Prepares FDA regulatory files such as PMAs, PMA Supplements and Amendments, 30 Day Notices, Annual Reports and 510ks.
  • Review and approve documentation related to various aspects of the design control process e.g. product release and product labelling
  • Participate in Regulatory agency audits.
  • Liaise and provide support to regulatory colleagues in the International regions.
  • Demonstrate and actively promote highest level of professional regulatory discipline.
  • Liaises with both middle and senior management on any regulatory issues relating to their area.

Qualifications and Experience

  • Bachelor’s degree, preferably in a scientific or engineering discipline
  • Working knowledge of current and proposed EU regulations for medical devices
  • Experience with FDA submission e.g. PMAs, PMA Supplements and Amendments, 30 Day Notices, Annual Reports and 510ks Preferred
  • 8+ years of professional work experience in the medical device industry
  • Strong project management skills (organized, meets deadlines, determines critical path items, good time management).
  • Ability to effectively manage multiple projects
  • Strong oral and written communication skills
  • Strong proficiency with Microsoft Excel, Word and PowerPoint applications
  • Effective written and oral communication, technical writing and editing skills
  • Working knowledge of product development process and design control Quality System Requirements In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For further information on this role in please contact Elaine Ferguson at or

Check out all our open jobs on our HERO Recruitment website –

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.