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Regulatory Affairs Manager

ID
14422
Location
Clare
Role Type
Permanent
Contact
Mark Wilson
Email
talent@hero.ie
Phone
+353 86 0449473
LinkedIn
click here
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Regulatory Affairs Manager
Clare
Hybrid

Our Client’s vision is to relentlessly reimagine healthcare, one diagnosis at a time. They have an amazing opportunity for someone with regulatory affairs experience at a leadership level to join their team on a permanent basis. You will be a part of the Quality and Regulatory Affairs team and report to the Senior Regulatory Affairs Manager. If you thrive in a leadership role in a fast-paced, global environment and want to work to build a world-class Quality and Regulatory Affairs organization, apply today!

Key Responsibilities

  • Providing leadership in overseeing regulatory activities for products under the responsibility of the client
  • Providing leadership for regulatory activities related to new product development, design changes and compliance projects.
  • Managing resources and developing direct reports to include performance objective setting, development planning, frequent development discussions and formal annual appraisals.
  • Oversee regulatory activities including product registrations/re-registrations globally, device modifications impacting registrations/licenses and market issues leading to Field Actions.
  • Select, develop and lead personnel in the Regulatory Affairs function.
  • Manage and provide resources for Design Change projects.
  • Assess the impact of global regulation changes on the registration of the AU product line globally.
  • Be involved in cross-functional projects contributing to problem solving and continuous improvement initiatives.

Key Requirements:

  • BSc in relevant scientific field with 9+ years’ related experience or MSc. / PhD in relevant field with 7+ years’ related experience.
  • Have 2+ years’ experience managing people.
  • Knowledge and understanding of the IVD Directive, IVD Regulation and associated harmonized standards, ISO13485 and the FDA QSRs.
  • Strong team leader.
  • Excellent written and communication skills.
  • Ability to work in a very busy environment and to manage change effectively.

It would be a plus if you also possess previous experience in:

  • Knowledge and understanding of 510K submissions, IVDR technical files and IVD product registrations in China.
  • Design Control experience and development of regulatory plans for projects.

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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