Adecco is currently hiring a temporary full-time Senior Regulatory Specialist to work for our client a leader in the healthcare field in Ottawa, ON. In this role you will work constructively, decisively, and collegiality with cross functional team members (regulatory, scientists, marketing, quality assurance, product development, etc.) to solve problems and communicate regulatory requirements. This role requires a bachelor’s degree in science and a minimum 7 years of experience in a regulated industry. Some of this experience in the regulatory industry must have been completed in Canada. If this sounds like you apply today!
Location: Ottawa, ON
Shifts: Monday to Friday | 8:00 am – 5:00 pm
Job type: Temporary | Full-time
Here's why you should apply:
4% vacation paid weekly
Paid weekly accurate and on time
Strong health and safety programs
Medical and dental benefits once qualified
Free training programs
New and quicker onboarding process
To work constructively, decisively, and collegiality with cross functional team members (regulatory, scientists, marketing, quality assurance, product development, etc.) to solve problems and communicate regulatory requirements.
Ability to understand technical/scientific information, international regulations and guidance and work closely with scientists, engineers, statisticians, etc.
Responsible to review and approval design changes and to provide regulatory assessment of the registration impact of the design change.
Responsible for writing technical and regulatory documents to support US and/or EU submissions, as well as creation, review and approval of labeling/labels compliant with international standards and regional requirements.
Responsible to effectively communicate applicable regulations and regulatory submission requirements to cross functional team members.
Communicate effectively verbally and in writing
Ability to write and edit technical documents
Ability to work effectively in a team environment
Ability to in fast-paced environment
Attention to detail
Problem solving skills
Must be legally eligible to work, and reside in Canada
Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
Minimum 7 years of experience in a regulated industry, preferred IVD, but may consider medical devices.
Minimum 5 years of experience in regulatory affairs but may consider research and development.
Has experience with regulatory requirements under IVDR, MDR, FDA 510k, and/or other country registration requirements.
Has experience in compile, prepare, review, and submit regulatory submission to authorities.
Experience with labeling regulatory requirements.
Has experience with reviewing and assessing design changes for the on-market products and evaluating worldwide registration impact of design changes.
Has experience working with cross functional teams.
If you are interested in the Senior Regulatory Specialist in Ottawa, ON, apply now and an Adecco recruiter will reach out soon!
Adecco is the largest staffing firm in Canada with over 40 locations and our passionate team is dedicated to find you a job you’ll love. We offer one of the best benefits packages in the whole entire staffing industry and we like to have fun at work!
To find out more about Adecco Perks and what we can do for you please visit the link here: https://www.adecco.ca/en-ca/working-with-a-staffing-agency/adecco-perks/