Regulatory Affairs Specialist – Abbott Medical Devices (Mississauga)

Location: Canada - Ontario - Mississauga

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 based at our Mississauga office within the Medical division and requires on‑site presence four days per week, with the option to work remotely one day.

What You’ll Do

Prepare robust regulatory applications to achieve departmental and organizational objectives.

Create, review and approve engineering changes.

Act as a team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.

Review and evaluate communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards to various local affiliates.

Maintain pertinent Canadian medical device regulations to ensure submission requirements are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are communicated to and understood by appropriate personnel.

Interface directly with Health Canada.

Support the product release process or reviewing and approving requests for product release.

Review protocols and report to support regulatory submissions.

Interface with a variety of management levels

May lead cross-functional project team

Support all Company initiatives as identified by management.

Comply with Canadian regulations, Company policies, operating procedures, processes, and task assignments.

Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

• Undergraduate university studies in a relevant field such as Life Sciences, Engineering, etc.
• Minimum of 3 to 5 years of relevant experience.
• Experience with preparing and filing Class II-IV Canadian medical device license applications, Investigational Testing Applications and working knowledge of the Canadian medical device regulations.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• 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.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Knowledge of regulatory requirements for medical devices in Canada.
• Knowledge of Canada’s Food & Drugs Act
• The annual base salary for this position ranges from $75,750 to $111,100 CAD. The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.
• 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.
• Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbottand on Twitter @AbbottNews and @AbbottGlobal.
• The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Regulatory Operations

DIVISION

MD Medical Devices

LOCATION

Canada > Mississauga : 6975 Creditview Rd #1

ADDITIONAL LOCATIONS

WORK SHIFT

Standard

TRAVEL

No

MEDICAL SURVEILLANCE

Not Applicable

SIGNIFICANT WORK ACTIVITIES

Not Applicable