Regulatory Affairs Specialist (Mississauga)
Job Location:
Mississauga - Canada
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
About Abbott
Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were 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 your 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 worldwide and one of the most admired companies by Fortune
- A company committed to diversity inclusion and supporting women and professionals across all levels
This position is based in Mississauga Ontario within the ADD (Diagnostics) division with occasional travel (5% domestic and international).
As a Regulatory Affairs Specialist you will support regulatory activities for diagnostic products to ensure compliance with Canadian regulations. You will contribute to regulatory submissions product lifecycle support and cross-functional collaboration.
This role is ideal for a detail-oriented professional who thrives in a fast-paced matrixed environment.
- Coordinate and prepare regulatory submissions for diagnostic and distributed products
- Respond to Health Canada requests for additional information
- Prepare and submit annual license renewals (medical device and establishment licenses)
- Conduct regulatory assessments for product changes
- Support Summary Report activities
- Assess impact of emerging regulations
- Ensure labeling advertising and promotional materials comply with regulations
- Support product release processes and approvals
- Review protocols and reports for regulatory activities
- Support internal and external audits
- Maintain regulatory submission databases and trackers
- Interface with Health Canada when required Collaborate with internal teams and external stakeholders
- Maintain effective and professional communication
- Support company initiatives
- Ensure compliance with regulations SOPs and policies
- Perform other duties as assigned
- Bachelors degree in Life Sciences Engineering or related field
- 13 years of relevant regulatory experience
- Experience preparing Canadian Class IIIV submissions
- Knowledge of Canadian medical device regulations
- Strong organizational and communication skills
- Ability to multitask and meet deadlines
- Postgraduate certificate in Regulatory Affairs
- RAPS certification
- Experience with Investigational Testing Applications
- Experience in a cross-functional/global environment
- English: Advanced (spoken and written)
- French: Basic functional
- Occasional travel (5%)
- Flexible work schedule
- Advanced MS Office proficiency
- Experience with regulatory systems/databases
Compensation:
68 250 $ - 100100 $
Follow your career aspirations to Abbott
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 diversity.
Connect with us at and on social media @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
Required Experience:
IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
