Abbott Regulatory Affairs Specialist - Medical Device in Lake Forest, Illinois
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, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
Assist in SOP development and review.
Provide regulatory input to product lifecycle planning.
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
Determine trade issues to anticipate regulatory obstacles.
Determine and communicate submission and approval requirements.
Participate in risk-benefit analysis for regulatory compliance Premarket:
Monitor applications under regulatory review.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Assist in preparation and review of regulatory submission to authorities Post-market:
Maintain annual licenses, registrations, listings and patent information.
Assist compliance with product post-marketing approval requirements.
Assess external communications relative to regulations.
Review regulatory aspects of contracts.
Assist with label development and review for compliance before release.
Submit and review change controls to determine the level of change and consequent submission requirements.
Ensure product safety issues and product-associated events are reported to regulatory agencies.
Provide regulatory input for product recalls and recall communications
Medical writing (e.g. technical files)
Restricted substances (e.g. REACH)
Compendial / standards
Import / export
Country specific regulatory support.
Preferred Experience, Education, etc.:
Regulatory work experience from medical device industry (e.g. IVD , diagnostics , or similar). Will also consider experience from pharmaceutical industry.
Experience or strong working knowledge of ISO 13485, 510k, or similar.
Bachelor's Degree (or equivalent); Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
2-3 years’ experience in a regulated industry (e.g., medical products , nutritionals ). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
Background / Skills / Knowledge Regulatory Knowledge of (as applicable):
· Regulatory history, guidelines, policies, standards, practices, requirements and precedents
· Regulatory agency structure, processes and key personnel
· Principles and requirements of applicable product laws
· Submission/registration types and requirements
· GxPs (GCPs, GLPs, GMPs)
· Principles and requirements of labeling
· Domestic and international regulatory guidelines, policies and regulations
Communication Skills or Ability to:
· Communicate effectively verbally and in writing
· Communicate with diverse audiences and personnel
· Write and edit technical documents
· Work with cross-functional teams
· Work with people from various disciplines and cultures
· Write and edit technical documents
· Negotiate internally Cognitive Skills or Ability to:
· Pay strong attention to detail
· Manage projects
· Create project plans and timelines
· Think analytically and critically
· Organize and track complex information
· Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
· Apply business and regulatory ethical standards
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org