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Senior Regulatory Affairs Specialist

Job description

About Your New Employer

  • A well-known multinational company in medical devices and pharmaceuticals production.
  • Changing peoples' and patients' lives every few seconds worldwide.
  • Wide scope for progression and upskilling.

About Your New Job

  • You will lead regulatory strategies for the Cork site projects and for local continuous improvement initiatives, as well as prepare and support regulatory submissions related to the company’s range of medical devices
  • You will be a key member of the New Product Introduction projects to ensure alignment with corporate commercialization strategies for Tier 1, 2, and 3 ROW markets
  • You will be responsible for maintaining site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDR, CMDCAS, and other International Regulations
  • Lead Product Support member of LCM projects to ensure documented continued device compliance to applicable market regulatory requirements
  • Participate in internal and external company regulatory /quality audits Lead RA representative for site change management with input into RA metric reporting
  • Maintain currency and accuracy of CE Technical Files aligned with device and process changes
  • Prepare regulatory dossiers for submission to Health Authorities and maintain them along the whole product life-cycle Support proactive engagement with key stakeholders
  • Lead preparation of regulatory submissions to FDA 510(k), PMA supplements and dossiers for other International Regulatory agencies.
  • Monitor global market regulatory changes, advise and/ or implement changes to ensure compliance.
  • Involvement in the general activities within the department, including improving and implementing integrated regulatory business processes.
  • Ensure continual Quality System compliance by adherence to established and evolving QS requirements.

 

What Skills You Need

  • At least 7 years' experience in an RA role within an FDA and/or ISO 13485 regulated medical device environment
  • Degree in an Engineering or Science discipline (ideally Master's Degree)
  • 1 year of supervisory experience
  • Flexible with the ability to adjust to changes in schedule, priorities
  • You must be able to communicate effectively with associates at all levels of the organization
  • Demonstrated excellent attention to detail
  • Excellent time management skills and proven ability to meet tight deadlines and ability to work under pressure
  • Thrive in a fast-paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously
  • Pro-active with proven ability to work under own initiative, problem solve and be a strong team player

What’s on Offer

Strong competitive salary along with benefits such as: 12% performance-related bonus scheme, Medical Insurance for you and your family members, Gym membership, Education Assistance. Additionally, after 6 months you will be entitled to a Pension contribution.

What’s Next​

For a confidential discussion on this or any other current job opportunity please contact Barbara Szatkowska on 086 796 1534 / barbara@sigmar.ie

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