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Regulatory Affairs and Market Quality Associate Manager

Req ID:  2990

Working Location: ONTARIO, RICHMOND HILL; Ontario, Toronto 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Regulatory Affairs and Market Quality Associate Manager (RA/MQ) position leads a team and serves as a subject matter expert and advisor on regulatory and post-market surveillance matters throughout in Canada. The RA/MQ Associate Manager will promote improvements which support the current Quality System, customer satisfaction improvement initiatives and realization of business goals. Additionally, the RA/MQ Associate Manager will be accountable to oversee the development of all of OCI’s SOPs, WIs and Bis within area of responsibility, perform periodic assessment activities to ensure quality system and all other applicable regulatory compliance is maintained

Job Duties

* Manage OCI RA/MQ staff in support of the maintenance of Olympus’ Quality Management System. Demonstrates all corporate and divisional expectations of people leaders which include developing employees, managing employee performance/engagement, promoting continuous improvement, managing department business/communications, driving organizational alignment, selecting/retaining talent, and consistently modelling excellence, integrity, and accountability.


* Support manufacturers as the Regulatory Representative in Canada. Develop and execute strategies for obtaining marketing authorizations in Canada including Class II and III Medical Device License Applications and amendments. Oversee and manage the local labelling control system to support the review of labelling, which include promotional, advertising and training collateral. 

 

* Act as an advisor to Olympus on Canadian regulatory and quality matters. Inform/consult manufacturers on Health Canada Medical Device Regulations through a Regulatory Intelligence Pathway. 


* Responsible for ensuring Olympus maintains valid registrations, including Medical Device Licences and Medical Device Establishment Licences. Mange and oversee the development, implementation and maintenance of OCI procedures relative to Health Canada’s Medical Devices Regulations, Quality Management Systems and relevant Business Instructions.


* Support the review of business and quality agreements, support sales opportunities and respond to Request for Proposals.  

 

* Manage and resolve regulatory and quality matters throughout product life cycle, including handling post-market surveillance activities such as Complaint Handling, Mandatory Problem Reporting and Recall support. Assist Olympus in the successful identification and resolution of quality issues and support corrective and preventative action activities to ensure specific requirements are met, including revising SOP/WI where required.


* Establish and maintain RA/MQ training programs for corporate OCI personnel to promote post-market surveillance activities, quality system compliance and advertising and promotional practices throughout the organization.


* Perform all other duties as directed.

Job Requirements

REQUIRED QUALIFICATIONS

* Bachelor of Science, Engineering, or Scientific discipline, or equivalent knowledge.

 

* Minimum of 5 years experience within Regulatory Affairs and/or Quality in Medical Device industry.

 

* Minimum of 3 years of management experience is required.

 

PREFERRED QUALIFICATIONS

* Certificate in Regulatory Affairs or equivalent preferred. 

 

* Strong analytical, organizational and communication skills required.

 

* Demonstrated knowledge of Canadian Medical Device Regulations. Familiarity with quality system development and ISO 13485 preferred.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our 100-year history, Olympus has focused on being true to society and making people’s lives healthier, safer and more fulfilling. 

Olympus Canada Inc. (OCI)—a subsidiary of Olympus Corporation of the Americas—manages the Company’s operations and workforce throughout Canada in roles such as sales, marketing, service, and support functions. Based in Richmond Hill, ON,  OCI is committed to developing our employees and supporting our local communities. For more information, visit olympuscanada.com and truetolife.com.
 

Olympus…True To You. True To Society. True To LIFE.

 

Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.  EOE Minorities/Females/Veterans/Disabled

 

Posting Notes: || Canada (CA) || Ontario (CA-ON) || Richmond Hill || 


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