Abbott Regulatory Affairs Specialist in Mississauga, Ontario
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Status: Permanent Full Time
Location: Mississauga, Ontario
This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the Canadian regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.
Prepares robust regulatory applications to achieve departmental and organizational objectives.
Creates, reviews and approves engineering changes.
Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards to various local and international affiliates.
Maintains 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 distributed to appropriate personnel.
May interface directly with Health Canada.
Supports the product release process or reviewing and approving requests for product release.
Reviews protocols and reports to support regulatory submissions.
Support all Company initiatives as identified by management.
Complies with Canadian regulations, Company policies, operating procedures, processes, and task assignments.
Maintains 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.
BA or BSc degree technical discipline preferred
Minimizes 3 years of experience, including a minimum of 2 years’ regulatory experience
Experience with Class II through IV medical devices
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 a t multiples levels in the organization. Multitasks, prioritizes and meets deadlines in a timely manger
Strong organization and follow-up skills, as well as attention to detail.
Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.
Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.
We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.
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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com