Senior Regulatory Affairs Specialist

Req ID: 10762

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

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.

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.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

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.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. 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. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: 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 reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

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)

Job Segment: QA, Quality Assurance, Manufacturing Engineer, PLM, Engineer, Technology, Quality, Engineering, Management

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