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Senior Regulatory Affairs Specialist

Job description

Senior Regulatory Affairs Specialist

This position offers valuable experience with the US and EU across a variety of technically interesting medical devices, which are either under development or commercially available.

Summary:

This position is responsible for coordinating, preparing, and maintaining regulatory submissions on a global level including European CE-marking and US FDA.

 Responsibilities:

  • Prepares regulatory submissions to regulatory authorities and/or distributors (including the FDA, Notified Bodies, Health Canada and other regulatory authorities).
  • Determines global regulatory pathways for various projects for EU, US and International product launches / product enhancements. Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
  • Interacts directly with international regulatory agencies on products / projects at reviewer level. Interacts with various levels of management, external agencies and companies. Works with engineers and technical experts to resolve potential regulatory issues and questions from Regulatory Agencies.
  • Maintains and enhances cross-functional team relationships. Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams. Maintains expertise in worldwide regulatory requirements; establishes and maintains positive relationships with regulators.
  • Participates in and assists with FDA facility inspections, Notified Body Audits, MDSAP and other governmental inspections as directed.
  • Performs other related duties and tasks, as required.

 

Summary of Minimum Qualifications:

  • Education and experience equivalent to a Bachelors’ Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience
  • Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), the Medical Device Regulation (2017/745, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485 and MDSAP
  • Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers
  • Self-motivated, self-directing, strong attention to detail and excellent time management skills
  • Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others
  • Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs
  • Possibility of Remote Working

 

To apply for this position please contact Keeva O’Shea at Sigmar Recruitment T: +353 91 749264 E:   koshea@sigmar.ie

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

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