Title: Regulatory Affairs Associate
Location: Abbott Park, Illinois
Responsibilities
- Provide regulatory input to product lifecycle planning.
- Evaluate proposed software, hardware and manufacturing changes for regulatory filing strategies.
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Participate in risk benefit analysis for regulatory compliance.
- Determine and communicate submission and approval requirements.
- Assist in preparation and review of regulatory submission to authorities.
- Assist compliance with product post marketing approval requirements.
- Submit and review change controls to determine the level of change and consequent submission requirements.
- Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and on-time delivery of project milestones. Establishes priorities of work assignments.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Participates in determining goals and objectives for projects.
- May organize and lead team meetings.
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.
Experience
- 2-3 years’ experience in a regulated industry (e.g., medical products, medical device software) or 2 years’ experience in software verification/validation, software quality assurance or experience as Medical Technologist with familiarity of software-driven clinical analyzers.
- Regulatory area with software knowledge is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Key Skills
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society or Medical Technologist; ASCP.)
Education
- BS Degree, In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
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.
