Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Our client is pleased to offer a new role for a Regulatory Affairs Specialist to join their Galway Medical Device manufacturing plant. As the Regulatory Affairs Specialist, you will provide technical expertise to understand regulatory impact regarding compliance and efficiency of proposed manufacturing changes. In this role, you will plan and implement strategies and activities required to ensure compliance to all US, EU and Company international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical device products.

As the Regulatory Affairs Specialist your role will include the following duties & areas of expertize.

  • Manage the FDA regulatory submission process, including authorizing submissions as applicable for product changes/transfers.
  • Oversee the development of dossiers for registration of products in countries outside the U.S, including authoring submissions.
  • Co-ordinate Change Notification for EU Design Dossier related to propriety product changes/transfers.
  • Establish and maintain regulatory information systems both electronically and hard copy.
  • Provide ongoing input to value improvement engineering teams on possible regulatory impact of the proposed changes.
  • Apply FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization.
  • Preparation of dossiers for product registrations outside the U.S.
  • Preparation of submissions to the U.S. FDA.
  • Monitoring of regulatory changes for impact to site quality system.
  • Participate in  site internal compliance program.
  • Preparation for external audits Able to identify and assess business risks for a given Regulatory strategy.

Education Requirements

  • Bachelor’s Degree in life sciences, technical (engineering), quality or related field is highly preferred, however a combination of education and relevant experience may be considered.
  • 5+ years’ experience in a regulatory position; at least 2 of which should be in the Medical Device sector.

For further information on this Regulatory Affairs role in Galway, please contact Marchon Monroe on 0860449473 / 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.

 

Marchon Monroe

JOB-11304

Regulatory Affairs Specialist

Marchon Monroe

Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie
mobile +353 86 044 94 73
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