Working Location: Ontario, Ottawa; Ontario, Hamilton; Ontario, Toronto

Workplace Flexibility: Hybrid

Job Description

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 role is responsible for the preparation of submission documents for product registration in Canada. The individual acts as an SME in Canadian regulatory affairs and will provide input in new product developments and sustaining initiatives. Additional responsibilities may include taking part in cross-functional projects, change management, process development, maintenance and mentoring junior staff.

Job Duties

• Provide guidance and oversight to global product RA SMEs in the creation of deliverables to support regulatory submissions in Canada.
• Establish effective working relationships with global product RA SMEs to coordinate, develop, submit product licence applications or the documentation to maintain product licence(s) throughout the product life cycle.
• 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
• Liaise with product RA and other stakeholders (e.g. 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.
• Support internal and third-party audits of Olympus Canada
• 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.

Job Qualifications

Required:

• BS/BA required preferably in engineering or life sciences, or advanced degree and/or other relative experience.
• 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.
• Excellent written and verbal communication skills.
• Ability to work in cross-functional teams.
• Attention to detail.
• Strong organizational skills.
• Previous experience working in a global environment; demonstrated sensitivity to cultural differences.
• 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). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus
• Comprehensive medical benefits and pension plan
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

Artificial Intelligence is not being utilized in the Olympus hiring process.

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