Telephone: 086 8395533
Senior Regulatory Affairs Specialist
Our client, a medical device company in Galway is currently looking to recruit a Senior Regulatory Affairs Specialist for their site.
At our Regulatory Affairs department focus on ensuring that all our products comply with Global Regulations and International Standards, across the Ventilation portfolio. As a Senior Regulatory Affairs Specialist, you will be responsible for managing regulatory submission activities for product maintenance for existing approved products.
- Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
- Prepare FDA submissions and CE Mark Technical Files for product changes and/or new products as required to ensure timely approvals for market released products.
- The completion and management of MDR activities/remediation as required by the business product portfolio.
- Provide support to currently-marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
- Maintain and update Insight database (used for tracking Worldwide Product Registrations)
- Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
- 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 (No equivalencies)
- 4+ 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).
- 4+ years regulatory submission experience and management of technical files for medical devices
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
- 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 Bimi on 086 8395533 / firstname.lastname@example.org
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