Delivering life-enhancing innovation worldwide.
Senior Clinical Affairs Specialist
Location
Ireland
Posted
4 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Affairs Specialist
Integer Holdings Corporation
• Ensure successful conduct of clinical programs for Integer technologies • Support compliance with regulatory, clinical, and standard requirements • Develop global clinical strategies for product submissions • Monitor clinical trials and work with regulatory bodies • Generate interim and final reports • Provide clinical perspective on field complaint investigations
Job Requirements
- Degree from higher education (Science, Engineering, Health Science, Nursing or related field)
- 5 years of documented professional experience, or 10 years without degree
- Experience in medical device or pharmaceutical industry
- Experience with implantable devices and/or high-risk device types
- Qualified per MEDDEV 2.7.1 (rev 4)
- Strong knowledge of medical device regulations
- Experience with feasibility, pivotal and post-market clinical trials
- Working knowledge with ERP systems (Oracle, Reliance)
- Experience with Minitab, Excel
- Strong leadership skills
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
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