Senior Regulatory Affairs Specialist
On-siteGalway, Connacht, Ireland
Job Summary
Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR. Support the development of domestic and international strategies for Class II and III medical devices while reviewing and approving design and manufacturing changes to ensure compliance. Represent Regulatory Affairs on cross-functional projects involving product development, manufacturing process changes, and continuous improvement efforts. Support international geographies to gain and maintain product approvals and assist with regulatory audits as required. Join the Vascular Therapies Team creating innovative technologies to diagnose and treat peripheral vascular disease.
Required Qualifications
- Level 8 Hons Bachelor Degree (or higher) in Engineering or related field
- 4+ years Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling, etc)
- Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as US 510(k)s and EU MDR technical documentation
- Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
- Previous experience supporting medical electrical equipment
- General understanding of product development process and design controls
- Working knowledge of US FDA, EU, and international regulations
- Ability to manage several projects
- Effective research and analytical skills
- Effective written and oral communication, technical writing and editing skills
- Works well in fast-paced cross-functional team environments
- Team player with excellent interpersonal skills
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