Abbott Biology Regulatory Affairs Specialist Vacancy – Apply Online
Abbott Biology Regulator Affairs 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 109,000 colleagues serve people in more than 160 countries.
Job Title: SR. REGULATORY AFFAIRS SPECIALIST – IMMUNOASSAY DIAGNOSTICS
Location: REGULATORY AFFAIRS UNITED STATES – ILLINOIS – ABBOTT PARK
EDUCATION AND EXPERIENCE YOU’LL BRING
- 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 of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- 3-4 years experience in a regulated industry (e.g., medical products, nutritional).
- 2-3(+) years of on-market medical products quality experience from manufacturers of medical devices/instruments or Nutritionals, in the following:
- Experience working on a team supporting study designs and/or submissions to FDA or providing responses to FDA regarding submissions.
- Experience designing and executing studies for FDA submissions and/or responses to FDA.
MAIN PURPOSE OF ROLE
As an individual contributor; the function of a Sr. 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 play a consultative role by partnering across business functions. The individual may assist in identifying data needed; obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
WHAT YOU’LL DO
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:
• Assist in SOP development and review
• Provide regulatory input to product life cycle 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
• Understand; investigate and evaluate 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
• Assess the acceptability of quality; pre-clinical and clinical documentation for submission filing
• Compile; prepare; review and submit a regulatory submission to authorities
• Monitor impact of changing regulations on submission strategies
• Monitor applications under regulatory review
• Monitor and submit applicable reports to regulatory authorities
• Evaluate proposed pre-clinical; clinical and manufacturing changes for regulatory filing strategies
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Maintain annual licenses; registrations; listings and patent information
• Assist compliance with product post-marketing approval requirements
• Review and approve advertising and promotional items to ensure regulatory compliance
• 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
• Analyze the input of cumulative product changes to current product submissions
• Contribute to the development and functioning of the crisis/ issue management program
• Ensure product safety issues and product-associated events are reported to regulatory agencies
• Provide regulatory input for product recalls and recall communications
Individuals may provide direction and guidance to exempt and/or skilled non-exempt levels of employees. Also may be asked to evaluate the performance of and assist in career development planning.
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. Work is reviewed upon completion for adequacy in meeting objectives. The individual is recognized as an expert in a workgroup.
Abbott Biology Regulatory Affairs