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Senior Regulatory Affairs SpecialistOlympus • Richmond Hill, ON, CA, L4B 4B3
Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Olympus • Richmond Hill, ON, CA, L4B 4B3
28 days ago
Salary
CA$80,955.00 yearly
Job type
  • Full-time
Job description

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: . 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 . 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. 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)
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Senior Regulatory Affairs Specialist • Richmond Hill, ON, CA, L4B 4B3

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