Senior Reg Affairs Specialist

Competitive
Permanent
Galway
13 Feb 2020
BBBH751148

Senior Regulatory Affairs Specialist in a well known Med Device company

I am delighted to be working with a well known Medical Device company in Galway. This is an exciting role for someone in the Reg Affairs sectory.

Responsibilities:

  • As part of a team of regulatory affairs professionals you provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
  • Prepare regulatory submissions for new products and product changes as required to ensure timely approvals for market release and/or clinical studies.
  • Provide post market maintenance support to commercial products as necessary to ensure ongoing regulatory approval. This includes supporting global re-certification activity, reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for filing directly with EU & US regulatory agencies and support other international agencies as required by product status.
  • Interact directly with external regulatory agencies (FDA, notified bodies etc.) and/or indirectly with international regulatory agencies on applicable projects/products.
  • Support regulatory compliance activities, including manufacturing site registration & regulatory agency audits as needed.
  • Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
  • Develop internal procedures to ensure continuous compliance with all regulatory requirements.
  • Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS)
  • Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.

KEY SKILLS & EXPERIENCE

  • We are looking for a qualified person to Level 8 Bachelor's Degree/Masters or equivalent in Science, Engineering or related discipline.
  • Regulatory experience is desirable, however, candidates with a minimum of 5 year's relevant experience will also be considered.
  • You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
  • You are experienced with Microsoft Word, Excel and PowerPoint, and knowledge of Adobe Acrobat, Data Management Systems are desirable
  • You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
  • You collaborate with others and create alignment with team members.
  • You set high standards and drive accountability in the execution of your responsibilities and you model ethical behavior.
  • You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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