Senior Regulatory Associate Product Development and Medical Devices

Position: Senior Regulatory Associate New Product Development and Medical Devices
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 environment 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 benefits 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 New 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 - $.

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…