Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Patient

Focus, Integrity, Innovation, Impact and Empathy. This role is responsible for supporting regulatory activities across the Olympus Canada Inc. (OCI) portfolio including establishment, assessment, and maintenance of appropriate regulatory requirements. The individual acts as an SME in Canadian regulatory affairs and will provide input in recent product developments and sustaining initiatives.

Additional responsibilities may include taking part in cross-functional projects, change management, process development, maintenance and mentoring junior staff. Provide guidance and oversight to global product RA SMEs in the creation of deliverables to support regulatory submissions in Canada. Assess impact of changes to applicable Canadian laws and regulations and identify impact to the business in collaboration with other stakeholders.

Support

Regulatory review of marketing/promotional materials and product labelling to ensure compliance with Canadian medical device regulations. R&D;) to support integration of Canadian regulatory requirements into product design controls in new product development. Support with the interpretation and impact of regulatory intelligence coming from Canada.

Support maintenance of regulatory files and databases to enable prompt and accurate access to regulatory information for new approvals and renewals. Participate in functional improvement projects. Provide reports to senior management regarding the status of key deliverables.





Develop and maintain documented regulatory procedures as required to assure consistent and compliant regulatory activities. Provide support for cross functional initiatives including manufacturing engineering, quality assurance, product development, and clinical affairs as required to assure regulatory compliance. Minimum of 5 years prior regulatory affairs experience in the medical device industry.

Working knowledge of Canadian medical device regulatory requirements required. Additional working knowledge of US regulatory requirements is preferred. Ability to travel up to 10% of time domestically and internationally.

The anticipated starting base pay range for this full-time position working at this location is $80,955.00 to $109,290.00 per year plus potential for annual bonus (subject to plan eligibility and other requirements).

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Competitive salaries, annual bonus Comprehensive medical benefits and pension plan Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance Offers onsite, hybrid and field work environments Dedicated Training Resources and Learning & Development Programs Artificial Intelligence is not being utilized in the Olympus hiring process. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection,



diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards.

Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-(phone hidden)).

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || Canada (CA) || Ontario (CA-ON) || Richmond Hill || Quality & Regulatory Affairs (QA/RA) #

📌 (Remote) Senior Regulatory Affairs Specialist - Medical Devices (Richmond Hill)
🏢 Olympus
📍 Richmond Hill