Our client, a medical device company in Galway is currently looking to recruit a Senior Regulatory Affairs Specialist for their site.
In the Regulatory Affairs department, we focus on harnessing our collective strength to deliver best-in-class solutions that benefit patients and our cross functional partners. Senior Regulatory Affairs Specialists are directly involved in regulatory activities supporting the global commercialization and sustaining of products on the market in compliance with all regulatory requirements.
- 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.
- Bachelor’s Degree Level 8 Bachelor’s Degree/Masters or equivalent in Science, Engineering or related discipline.
- 5+ years industry experience Quality Assurance or Regulatory Affairs for a Medical Device or Pharmaceutical Industry.
- Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483/MDD and MDR) and/or Pharmaceutical GMP (21 CFR 210/211).
- Experience with international standards (ISO, GHTF, ICH).
- Experience with FDA and international regulatory agency requirements, CE marking (AIMD and MDD).
- Experience with medical devices (510(k), PMA), pharmaceuticals, or combination products (drug/biologic-device).
- Experience working with cross-functional teams.
- Experience working with technical documentation.
- Project management skills. Product development experience.
- Knowledge of procedures and systems.
- Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.
- Strong oral and written communication skills.
- Effective interpersonal skills. Effective team member.
- Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
- Ability to effectively manage multiple projects and priorities.
- Proficient skills with MS Word, MS Outlook, MS Excel.
For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Clara Burke on 086 8168273 / email@example.com
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