Abbott Diagnostics is looking for a qualified and motivated individual to join the team responsible for the successful transition of CE-marked products to the European Union In Vitro Diagnostics Regulation (IVDR). This individual will lead the product assessment process, applying domain knowledge in IVD products to complete detailed assessments and implementation plans for the IVDR transition. This individual will be the subject matter expert for project management and implementation of best practices.
Primary Job Function:
As an individual contributor; the function of a Regulatory AffairsProject Manager is to combine knowledge of scientific; regulatory and business issues to enable products that are developed; manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed; obtain these data and ensure that they are effectively presented for the registration of products worldwide.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
• Develop new regulatory policies; processes and SOPs and train key personnel on them
• Evaluate regulatory risks of division policies; processes; procedures
• Provide regulatory input to product lifecycle planning
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
• Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
• Assist in regulatory due diligence for potential and new acquisitions
• Utilize technical regulatory skills to propose strategies on complex issues
• Determine submission and approval requirements
• Identify emerging issues
• Monitor trade association positions for impact on company products
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Recruit; develop and mentor regulatory professionals
• Assess the acceptability of quality; preclinical and clinical documentation for submission filing
• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
• Compile; prepare; review and submit regulatory submission to authorities
• Monitor impact of changing regulations on submission strategies and update internal stakeholders
• Monitor applications under regulatory review
• Communicate application progress to internal stakeholders
• Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
• Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Provide strategic input and technical guidance on regulatory requirements to development teams
• Manage and execute preapproval compliance activities
• Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
• Ensure compliance with product post marketing approval requirements
• Review and approve advertising and promotional items to ensure regulatory compliance
• Ensure external communications meet regulations
• Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
• Actively contribute to the development and functioning of the crisis/issue management program
• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
• Report adverse events to regulatory agencies and internal stakeholders
• Provide regulatory input for product recalls and recall communications
Supervisory / Management Responsibilities:
Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also may mentor other department members.
Position Accountability / Scope:
Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues; and must assure that deadlines are met. Effectively communicate; prepare; and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs.
Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Minimum Experience / Training Required:
2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 4-5 years experience in a regulated industry (e.g., medical products, nutritionals).
- Knowledge of IVD products including relevant standards and regulations.
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
- Demonstrated success in leading complex projects. Proficient in use of project management tools, such as Microsoft Project.
- 5+ years of experience in regulatory affairs, quality assurance, research and development, product support or related area.
- Higher education may compensate for years of experience.