Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)

Regulatory Affairs Manager – International Compliance Operations – Diabetes Care (on-site) job at Abbott | Abbott Careers

• Assist in SOP development and review
• Provide regulatory input to product lifecycle planning
• Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
• Determine trade issues to anticipate regulatory obstacles
• Determine and communicate submission and approval requirements
• Participate in risk benefit analysis for regulatory compliance
• Assess the acceptability of documentation for gap assessments submitted
• Monitor impact of changing regulations on submission strategies
• Assess external communications relative to regulations
• Review regulatory aspects of contracts
• Assist with label development and review for compliance before release
• Contribute to the development and functioning of the crisis/issue management program
• Provide regulatory input for product recalls and recall communications
• Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues
• Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations
• Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence

• Bachelor’s degree or an equivalent combination of education and work experience
• Minimum 8 years’ experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices
• Ability to work effectively on project teams
• Strong organizational skills with the ability to juggle multiple and competing priorities
• Scientific writing experience is required
• Working knowledge of QSR, ISO, and EN standards
• Strong working knowledge of regulatory requirements for European community, Japan, Canada, and other countries
• Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
• 401k matching
• Health insurance
• Flight privileges

Abbott is a global healthcare leader that helps people live more fully at all stages of life