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

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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of Ottawa office for the Point of Care, Diagnostics division. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including Chemistry, Electrolytes, Hematology, Blood Gases, Coagulation, Endocrinology, Cardiac Markers, Neurology, and Informatics. As the Senior Specialist Regulatory Affairs, you will be responsible for managing the regulatory reviews associated with design changes in the i-STAT product portfolio to meet global regulatory requirements.

What You'll Do

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.

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.