Regulatory Affairs Specialist

4 weeks ago

Mississauga, Ontario, Canada Abbott Laboratories Full time
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 is located in our Mississauga office in the Core Lab division. At Abbott – Core Lab, we're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

Key Responsibilities

As a Regulatory Affairs Specialist, you will be responsible for:

  • Coordinating and preparing submissions required for registration for Core Lab products and distributed products in compliance with applicable regulations.
  • Assisting in responding to additional information requests and/or other requests received from Health Canada.
  • Completing regulatory assessments for product changes.
  • Supporting the Summary Report activities.
  • Ensuring that labeling, advertising and promotional activities meet applicable regulatory requirements.
  • Assisting with impact assessments of emerging regulations.
  • Preparing and submitting annual medical device license and establishment license renewals by due date prescribed by Health Canada.
  • Supporting internal and external audits.
  • Maintaining electronic Regulatory Affairs submission profiles and internal trackers.
  • Supporting the product release process or reviewing and approving requests for product release.
  • Reviewing protocols and reports to support regulatory submissions and activities.
  • Supporting all Company initiatives as identified by management.
  • Complying with Canadian regulations, company policies, operating procedures, processes, and task assignments.
  • Maintaining positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree.
  • 1-3 years of experience in a similar role.
  • Experience with preparing and filing Class II-IV Canadian medical device license applications, Investigational Testing Applications and working knowledge of the Canadian Medical Devices Regulations.
  • Knowledge of regulatory requirements for medical devices in Canada.
  • Knowledge of Canada's Food & Drugs Act.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasking, prioritizing and meeting deadlines in a timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
Preferred Qualifications

We also welcome candidates with:

  • Post-graduate certificate in Regulatory Affairs.
  • RAPS certification.
  • Experience working in a broader enterprise/cross-division business unit model.
About Abbott

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Ontario, Canada Brenntag Specialities Full time

    At Brenntag Specialities, we are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mississauga. This role is responsible for providing support to the organization in maintaining compliance and addressing needs related to new and existing business as they pertain to regulatory matters.Key ResponsibilitiesManage risk considering legal...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche AG Full time

    Program ManagementAt F. Hoffmann-La Roche AG, we are seeking a skilled Regulatory Affairs Specialist to join our team. This role will be responsible for delivering global regulatory strategy and executing clinical projects in our portfolio, ensuring the development and maintenance of Roche product licenses to meet patient needs.In this position, you will...

  • Regulatory Affairs Specialist, Oncology

    3 weeks ago

    Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Key Responsibilities:As a Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies for rapid approvals with optimal labeling for products within the Oncology therapy area. You will also be accountable for a portfolio of products, including the preparation, filing, and approval of regulatory submissions to aggressive...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Ontario, Canada Q&C Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Q&C. As a key member of our Regulatory Services department, you will play a critical role in maximizing and protecting the commercial interests of our clients.Key ResponsibilitiesDrive the registration of various products according to applicable...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Prepare and submit regulatory documents, including NDSs, SNDSs, CTAs, and NCs, to achieve aggressive targets.Build and maintain relationships with Health Canada contacts to improve submission approval times and achieve...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Ontario, Canada Q&C Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Q&C. In this role, you will be responsible for maximizing and protecting the commercial interests of our clients by driving product submissions to Health Canada and ensuring compliance with applicable regulations.Key ResponsibilitiesPrepare and submit NHP PLAs -...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Ontario, Canada Brenntag Specialities Full time

    We are seeking a highly skilled Regulatory Affairs Manager to join our team at Brenntag Canada Inc.Job Summary:The successful candidate will be responsible for providing support to the organization in maintaining compliance and addressing needs related to new and existing business as they pertain to regulatory matters.This role will involve managing risk...

  • Regulatory Affairs Specialist

    1 month ago

    Mississauga, Ontario, Canada Q&C Full time

    Job Title: Lead Regulatory Affairs ConsultantWe are seeking a highly skilled Lead Regulatory Affairs Consultant to join our team at Q&C. As a key member of our Regulatory Services department, you will play a critical role in maximizing and protecting the commercial interests of our clients.Key Responsibilities:Drive the registration of various products...

  • Regulatory Affairs Specialist

    1 month ago

    Mississauga, Ontario, Canada Q&C Full time

    Job Title: Lead Regulatory Affairs ConsultantWe are seeking a highly skilled Lead Regulatory Affairs Consultant to join our team at Q&C. As a key member of our Regulatory Services department, you will play a critical role in maximizing and protecting the commercial interests of our clients.Key Responsibilities:Drive the registration of various products...

  • Regulatory Affairs Specialist

    4 weeks ago

    Mississauga, Ontario, Canada Q&C Full time

    Job Title: Lead Regulatory Affairs ConsultantWe are seeking a highly skilled Lead Regulatory Affairs Consultant to join our team at Q&C. As a key member of our Regulatory Services team, you will play a critical role in maximizing and protecting the commercial interests of our clients.Key Responsibilities:Drive the registration of various products according...

  • Regulatory Affairs Specialist

    4 weeks ago

    Mississauga, Ontario, Canada Q&C Full time

    Job Title: Lead Regulatory Affairs ConsultantWe are seeking a highly skilled Lead Regulatory Affairs Consultant to join our team at Q&C. As a key member of our Regulatory Services team, you will play a critical role in maximizing and protecting the commercial interests of our clients.Key Responsibilities:Drive the registration of various products according...

  • Regulatory Affairs Consultant

    1 month ago

    Mississauga, Ontario, Canada Q&C Full time

    Job Title: Lead Regulatory Affairs ConsultantQ&C is seeking a highly skilled and experienced Lead Regulatory Affairs Consultant to join our team. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support to our clients in the pharmaceutical industry.Key Responsibilities:Develop and implement...

  • Regulatory Affairs Consultant

    1 month ago

    Mississauga, Ontario, Canada Q&C Full time

    Job Title: Lead Regulatory Affairs ConsultantQ&C is seeking a highly skilled and experienced Lead Regulatory Affairs Consultant to join our team. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support to our clients in the pharmaceutical industry.Key Responsibilities:Develop and implement...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Key Responsibilities:Develop regulatory strategies to ensure timely product approvals with optimal labeling for products within therapy areas or for submissions within specialization areas.Accountable for a portfolio of products, including the preparation, filing, and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc.) to aggressive...

  • Regulatory Affairs Manager

    3 weeks ago

    Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Regulatory Affairs ManagerJob SummaryThe Regulatory Affairs Manager provides leadership and support to the Regulatory Affairs department, ensuring compliance with industry regulations and government codes. This role involves reviewing and assessing emerging regulatory issues, industry standards, and government initiatives, and providing advice and guidance...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Ontario, Canada Q&C Full time

    The Regulatory Affairs Specialist role at Q&C focuses on maximizing and protecting the commercial interests of our clients. Our consultants work closely with marketing, quality assurance, project management, and legal teams to ensure timely drug development, submissions, and product compliance activities.We are seeking consultants with in-depth regulatory...

  • Regulatory Affairs Manager

    1 month ago

    Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Regulatory Affairs ManagerAbout the RoleAlectra Utilities Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing leadership and support to ensure compliance with industry regulations and government policies.Key ResponsibilitiesLead and manage...

  • Regulatory Affairs Manager

    1 month ago

    Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Regulatory Affairs ManagerAbout the RoleAlectra Utilities Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing leadership and support to ensure compliance with industry regulations and government policies.Key ResponsibilitiesLead and manage...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Ontario, Canada BAXTER Full time

    Key Responsibilities:- Prepare and submit regulatory documents, including NDS, SNDS, Medical Device Applications, and CTAs, according to current Health Canada requirements.- Collaborate with stakeholders to provide accurate and timely responses to Health Canada, identifying priorities and key issues in complex situations and achieving resolution with minimal...

  • Regulatory Affairs Specialist

    4 weeks ago

    Mississauga, Ontario, Canada Q&C Full time

    Job Title: Lead Regulatory Affairs ConsultantThe Lead Regulatory Affairs Consultant plays a crucial role in maximizing and protecting the commercial interests of our clients. This position requires close collaboration with various teams, including marketing, quality assurance, project management, and legal, to ensure timely completion of drug development,...