Regulatory Affairs Specialist

Posted 20 June 2024
Salary €55,000 - €65,000
LocationCounty Offaly
Job type Permanent
Discipline Quality & Laboratory
Reference10942-M
Contact NameEmma O’Connor

Job description

What you need to know

Matrix Recruitment are currently recruiting for a Regulatory Affairs Specialist for our client based in County Offaly who specialises within the Healthcare Distribution Industry. Our client is currently expanding and experiencing an exciting period of growth and innovation within the healthcare industry. With new opportunities on the horizon and significant advancement in projects and capabilities they are now looking to expand their team.

The Regulatory Affairs Specialist, reporting directly to the Managing Director, will enjoy the autonomy to ensure all products in the distribution centre meet and exceed internal and external regulatory standards, contributing to the company's commitment to long term success.

This is a permanent position with an immediate start.

 

Your new job

Key duties & responsibilities:

  • Identifying if products are compliant or non-compliant with all regulatory requirements within the client’s current market and cooperate with non -complaint potential suppliers.

  • Manage the regulatory changes connected to UKCA and MDR and monitor changing or evolving global regulations.

  • Ensure all products and paperwork are audit ready for customers, HPRA assurance, WHO inspections and supplier audits.

  • Lead strategic quality improvement projects that strengthen the company's long-term success.

  • Oversee Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems.

  • Managing assessments of any device/ quality systems changes.

  • As the ISO Quality Management representative, manage all correspondence with Notified Body to achieve certification.

What are we looking for?

  • A minimum of 3 years’ experience in a regulatory position within the medical device/healthcare industry is essential.

  • Qualification in Regulatory Affairs or another related field is essential

  • The desired candidate will be a “self-starter” and be able to operate with minimal supervision.

  • Strong knowledge of ISO, MDD, MDR & CE/UKCA.

  • A strong sense of time and task management and have excellent attention to detail.

  • Have a systematic way to review processes and be capable of leading change and continuous improvement.

Apply for this job now by sending in a Word version of your CV or reach out to Emma O’Connor on +353 90 640 9215or email emma@matrixrecruitment.ie

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position.

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