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Principal Regulatory Affairs Specialist

Location
Galway
Role Type
Permanent
Contact
Mark Wilson
Email
talent@hero.ie
Phone
+353 86 0449473
LinkedIn
click here
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Principal Regulatory Affairs Specialist
Hybrid
Galway

Interested in becoming part of a thriving Medical Device business that focuses on cutting edge technology and impact the lives of millions worldwide? Our client a global Medical Device manufacturer are hiring due to continued business growth. They are seeking a Senior and Principal level Regulatory Affairs professional to join them on a permanent basis.

Key Responsibilities

  • Directs and influences the preparation of documentation to support high quality regulatory submission dossiers. 
  • Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies for changes to existing products.
  • Engages with regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing regulatory strategies.
  • Engages with global international regulatory partners to support regulatory strategy for changes to existing products.
  • Leads regulatory filings to support submissions, license renewal and annual registrations.
  • Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes.
  • Mentors and coaches’ other employees within the department and provides leadership support to ensure strong talent development. 
  • Keeps abreast of regulatory procedures and changes. Supports industry advocacy activity to shape the future of evolving regulatory requirements.
  • Develops internal procedures to ensure continuous compliance with all regulatory requirements
  • Influences clinical evidence strategy to support labelling content, marketing claims and regulatory compliance.
  • Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed. 
  • Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives. 

Key Requirements

  • We are looking for a qualified person to Level 8 Science or Engineering Degree/Masters. A Regulatory Affairs qualification is desirable, but not mandatory. 
  • Regulatory experience in Medical Devices is required.
  • You are a recognized expert, capable of managing large projects or processes.
  • You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams. 

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

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