What are the responsibilities and job description for the Regulatory Specialist Sr position at Abbott?
Title: Regulatory Specialist Sr
Location: Alameda, CA
Duration: 6 Month's
100% Onsite
Experience Required
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
Location: Alameda, CA
Duration: 6 Month's
100% Onsite
Experience Required
- Years Experience: Must have 7 years of experiences in Medical Device Regulatory Affairs
- Considered as highly experienced with regulatory change assessments.
- Working knowledge in US Medical Device Submissions.
- Participates in some of the following: continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, regulatory policy and intelligence.
- Ensures timely approval of new medical devices and continued approval of marketed products.
- Serves as regulatory representative to cross-functional teams.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.