Build your Future with Fresenius Kabi Can ada We are Committed to Life As a part of Fresenius Kabi Canada, you can enjoy an exciting career, a company culture based on a clear purpose and principles, and the knowledge that your work makes a real difference.
We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence, because our customers deserve nothing less and our customers are at the heart of every one of our goals.
Senior Regulatory Associate New Product Development and Medical Devices As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and presence in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
WHAT WE OFFER!
At Fresenius Kabi Canada we foster a collaborative workplace where employees are encouraged to share ideas and contribute to meaningful work. We offer unique learning opportunities to grow and build your career. In addition, we value each and every contributor and offer various benefits and rewards (as applicable) including:
Company paid health and dental advantages that start on your first day of employment
Generous vacation plan
Paid float days and paid sick days
Employee assistance program
Casual office dress code
Employee recognition program
Perkopolis & Goodlife Discounts
Professional growth and development opportunities
We are currently seeking a full-time temporary (12 months) Senior Regulatory Associate Recent Product Development and Medical Devices to join our team!
Hybrid role, on-site requirement 3 days/week
The pay range for this role is: $90,000.00 - $100,000.00.
Placement within the range will be determined based on relevant skills, experience, qualifications, and internal equity. The final offer will reflect the successful candidate's background and demonstrated capabilities.
This position is an existing vacancy within the organization.
MAIN RESPONSIBILITIES




Participates actively in project team meetings and provides Canadian regulatory requirements to the respective functions within the project team in accordance to the current Health Canada and ICH requirements
Compiles and submits regulatory dossiers (e.g. NDSs, ANDSs, SNDSs, SANDSs, and other applications) or medical device regulatory applications in accordance to the current Health Canada guidance documents as required
Conducts accurate regulatory assessment for post-approval changes for pharma and devices and identifies level of filing and data requirements
Communicates with internal and external stakeholders to obtain application documents
Supports the Quality and Marketing Departments in the change control and product launch processes as required
Manages own projects independently as per assigned deadline and reports any delays to management
Provides regular reports to management on the status of regulatory submissions, licenses/clearances and registrations
QUALIFICATIONS
Bachelor of Science Degree in one of Chemistry, Microbiology, Biology, Pharmacology or other life science is required at minimum
Completion of a college regulatory affairs program is an asset
Minimum of four years of pharmaceutical experience in a regulatory affairs capacity for pharma and/or medical devices
SKILLS
Strong knowledge of chemistry and manufacturing requirements for pharmaceuticals
Strong knowledge of Health Canada Medical Device regulations and understanding of global regulatory requirements
Strong communication skills (written and verbal)
Able to understand customer needs and the ability to collaborate both inside and outside the organization
Strong computer skills in Microsoft Office 365®. Adobe Acrobat and familiarity with eCTD Document Management System are required.
Strong attention to detail
Self-motivated
Proven ability to adhere to standards and procedures and maintain confidentiality
Strong commitment to quality and accuracy
Analytical skills to assess problems and present solutions are required
Ability to work well under pressure in a team-based environment
MORE ABOUT US!




As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.
Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually.
Inclusion and Equal Opportunity Employment
At Fresenius Kabi Canada, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work. We are taking actions to tackle issues of inequity and systemic bias to support our diverse talent, clients and communities. We are an equal opportunity employer.
In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, we are committed to providing accommodations and will work with candidates to meet their needs and provide an accessible candidate experience. If you are a person with a disability and require assistance during the application process, please let us know ([email protected] ). We welcome members of all backgrounds, experiences and perspectives to apply.
Artificial Intelligence (AI) Use in Recruitment:
Fresenius Kabi uses AI-supported tools to help compare applicant résumés with job requirements and identify potential matches. These tools do not make hiring decisions. All candidate reviews, selections, and decisions are made by our recruitment team.

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📌 Senior Regulatory Associate New Product Development and Medical Devices (Ontario)
🏢 Fresenius Kabi Canada
📍 Ontario