Senior Regulatory Affairs Specialist

  • Location

    Republic of Ireland, Republic of Ireland

  • Sector:

    Life Science, Quality, Executive, Science

  • Job type:


  • Salary:


  • Contact:

    Kathryn Whyte

  • Contact email:

  • Job ref:


  • Published:

    over 2 years ago

  • Expiry date:


Senior Regulatory Affairs specialist

The Senior RA specialist drives and/or supports key projects in which regulatory affairs is a critical component or drive. It combines knowledge of scientific, regulatory and business acumen to ensure that products are developed, manufactured and distributed in compliance with applicable regulatory requirements and standards. This function exhibits a high degree of independent judgment and execute on plans that directly impact the operational results of the business unit.

The Senior RA specialist supports a broad range of projects and participates in cross-functional teams as the regulatory expert.

Main responsibilities:

  • Develops regulatory strategies and provides guidance and expertise.

· Compiles and communicates regulatory requirements to cross-functional groups in a concise and precise manner.
· Reviews and approves the project documentation (design reports, labelling, etc.).
· Ensures that updates to the Technical Files and international registrations are conducted appropriately.
· Develops tactics supporting first to market commercial opportunities and minimizes time to product launch.
· Works closely with the other functions (QA, R&D, Medical Affairs…) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation.
· Identifies roadblocks, defines problems based on data / facts and effectively communicates with his/her peers, project teams or management (as appropriate) for seeking solutions.

  • Supports continuous improvements in regulatory processes, QMS processes or company-wide initiatives.

Be Qualified

  • BSC in Electronics or Biomedical engineering discipline, or equivalent proven experience.

· Minimum of 7 years' experience in Regulatory Affairs within medical devices industry with exposure to programmable electrical equipment. Alternatively, a strong technical experience in the field of Programmable Electrical Medical Systems including exposure to regulatory affairs requirements;
· Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series…); knowledge of FDA regulatory requirements is a plus.
· Knowledge of software, instrument and disposable design practices.

  • Experience with representing Regulatory Affairs in multiple environments (i.e. R&D, operations, marketing, medical affairs, etc.)

Skills and abilities:

  • Demonstrated analytical and planning skills, together with the ability to take decisions and to translate those decisions into actions and priorities;
  • Demonstrate interpersonal skills including strong communication and negotiation skills;
  • Cultural sensitivity, open-mindedness and flexibility to work effectively in a dynamic multinational, matrix organisation;
  • Continuous improvement driven: Detects significant opportunities for improvement (cost, cycle time, process, quality, etc.). Analyses feasibility, participates and possibly leads in developing, executing, or monitoring implementation plan demonstrating strategic thinking as well as attention to detail.
  • Open to travel (EU and outside EU).

For additional information on this and similar position please contact Kathryn on 016455250 or email Kathryn.whyte