Senior Specialist Regulatory Affairs - Abbott Point of Care (Ottawa)

at  Abbott Laboratories

ABOUT ABBOTT

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

REQUIRED QUALIFICATIONS

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 is helpful.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Typically requires 3+ years of experience in a regulated industry (e.g. medical products, nutritional’s) to develop the competence required to meet the responsibilities of the position.
2+ years of experience in regulatory preferred but may consider quality assurance, research and development support, scientific affairs, operations, or a related area.
Regulatory knowledge of regulatory history, guidelines, policies, standards, practices, requirements, and precedents.
Knowledge of regulatory principles and requirements of applicable product laws.
Knowledge of regulatory submission/registration types and requirements.
Knowledge of GxPs (GCPs GLPs, GMPs).
Knowledge of principles and requirements of promotion, advertising, and labeling.
Knowledge of international treaties and regional, national, local, and territorial trade requirements, agreements, and considerations.
Knowledge of domestic and international regulatory guidelines, policies and regulations and ethical guidelines of the regulatory profession, clinical research, and regulatory process.
Broad knowledge of various technical alternatives and their potential impact on the business.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Responsible for timely regulatory reviews and appropriate escalations of changes to products in the i-STAT portfolio.
Ensure that regulatory reviews are documented in compliance with applicable internal and external policies and procedures.
Evaluate FDA and EU guidance, policies related to product changes and communicate potential risk and impact to stakeholders supporting the i-STAT portfolio.
Continually assesses regulatory review of design change-related processes and procedures to enhance efficiencies and compliance and recommend/implement policy and/or process changes as needed.
Work independently and recognize when issues need to be elevated to management.
Participate in regulatory intelligence gathering activities and maintain knowledge of US, Health Canada, EU and ROW regulatory requirements.
Develop and update training resources on regulatory review process.
Serve as primary point of contact and RA representative for all matters related to design changes to APOC products.
Provide support to Regulatory Affairs teams (e.g. labelling, ad & promo review) to ensure APOC products remain in compliance with global regulatory requirements.
Mentor other regulatory professionals.