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Senior Regulatory Affairs Specialist

Location: Galway, Republic of Ireland
Salary: Negotiable
Posted: about 2 months ago
Role type: Contract
Contact name: Laura Gallagher
Contact email: laura.gallagher@hrmrecruit.com

Job description

Our client is a global medical device healthcare solutions company who are committed to improving lives through medical technologies, services, and solutions. They operate across 350 facilities in 150 countries, with an innovative portfolio of over 46,000 patents. They are currently looking for an experienced Senior Regulatory Affairs Specialist, provide regulatory support for new products/therapies and changes to existing products.

The Role

This is an exciting 12-month contract role.

Key Responsibilities would include:

  • Directs or performs coordination and preparation of document packages for regulatory submissions.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
  • Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
  • May direct interaction with regulatory agencies on defined matters.
  • Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
  • Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS).

The Person

In order to be considered for this exciting daily rate Senior Project Engineer role, specific requirements for the successful candidate would include:

  • Bachelor's degree required - Engineering/Science/Quality.
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
  • Experience working with Class III Medical Devices.
  • Experience or working with regulatory files for USA / EU.

What's on offer:

  • Exciting long-term daily rate contract role within a leading global healthcare solutions company.
  • Opportunity to work within a global leader giving you access to build your portfolio within the medical device industry.
  • Potential for a long-term opportunity within the organisation.

To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.

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Laura Gallagher

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