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Regulatory Affairs Specialist III - Medical Device
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Job Description
- Req#: R-01241814
Employer Industry: Scientific Research and Development
Why consider this job opportunity:
- Competitive remuneration and annual incentive plan bonus
- Healthcare benefits and a range of employee benefits
- Outstanding career and development prospects
- Exciting company culture emphasizing integrity, intensity, involvement, and innovation
- One team of 100,000+ colleagues sharing common values
What to Expect (Job Responsibilities):
- Participate in New Product Development teams, providing regulatory requirements
- Analyze product changes, define regulatory impacts, and resolve gaps
- Collaborate with Quality, Engineering, and other cross-functions for Post Market Surveillance activities
- Engage with regulatory agencies and authorities to resolve questions or issues
- Research industry standard methodologies and emerging trends in regulatory compliance
What is Required (Qualifications):
- STEM related Bachelor's degree or 4+ years of experience in product compliance, quality, regulatory affairs, or engineering
- Involvement with product development and sustaining engineering activities
- Working within Product Lifecycle Management systems
- Participating in post-market surveillance activities
- Exposure to manufacturing environments, especially laboratory or medical devices
How to Stand Out (Preferred Qualifications):
- Experience in risk assessment activities, such as ISO 12100 or ISO 14971
- Functional understanding of manufacturing processes and product engineering change controls
- Awareness of international regulations, standards, and requirements for safety, EMC, wireless, environmental, and circular economy
#ScientificResearch #RegulatoryCompliance #CareerGrowth #Innovation #EmployeeBenefits
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