Trainee in Infosec GRC at SEK developing security policies and handling risk assessments. Focusing on ISO standards and technical compliance across projects.
About the role
- Senior Regulatory Affairs Specialist in the Vascular division at Abbott ensuring product compliance and regulatory submissions for innovative healthcare solutions.
Responsibilities
- Provide regulatory input to product lifecycle planning
- Assist in development of regional regulatory strategy
- Assess regulatory implications for product approval
- Compile, prepare, review and submit regulatory submissions
- Maintain annual licenses, registrations, and listings
- Assist in compliance with product post-marketing approval requirements
Requirements
- Bachelor's Degree in a related field OR equivalent combination of education and work experience
- 3-4 years of experience in a regulated industry
- 2-3 years of experience in regulatory preferred or related area
- Effective verbal and written communication skills
- Strong organizational and follow-up skills
- Good judgment within policy and regulations
Benefits
- Health insurance coverage through the Health Investment Plan (HIP) PPO medical plan
- Retirement savings plan with high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit for bachelor's degree
- Recognition as a great place to work
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