Regulatory Affairs Associate
Roles and Responsibilities:
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Core job responsibilities for this function may include:
- 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 to assess regulatory implications for approval.
- Determine and communicate submission and approval requirements.
- Participate in risk-benefit analysis for regulatory compliance Premarket
- Monitor applications under regulatory review.
- Evaluate proposed changes for regulatory filing strategies.
- Assist in preparation and review of regulatory submission to authorities' post-market
- May help maintain annual licenses, registrations, and listings.
- Assist compliance with product post-marketing approval requirements.
- Assess external communications relative to regulations.
- 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.
- Maintain submission files (e.g., technical files)
- Compendial / standards
- Import / export
- Country specific regulatory support.
Education and Experience:
- 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.
- Required Qualifications
- 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.)
- 3 years' experience in a regulated industry (e.g., medical products, nutritional). 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.
- 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
- 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
- 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