Manager, Regulatory Affairs & Quality Assurance

Job title: Manager, Regulatory Affairs & Quality Assurance

Job description: Topcon Healthcare sees eye health differently. Our vision is to empower providers with smart and efficient technologies for enhanced patient care. Keeping pace with the ever-changing landscape of the healthcare industry, we offer the latest integrated solutions including advanced multimodal imaging, vendor-neutral data management and groundbreaking remote diagnostic technology. A globally-oriented business, Topcon is focused on developing solutions towards solving societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, access to healthcare and physician shortages. By investing in value-driven innovations, Topcon works to enable people to enjoy good health and a high quality of life.

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JOB PURPOSE

The Manager, Regulatory Affairs & Quality Assurance is responsible and accountable for the quality management systems for pharmaceutical and medical device products as well as regulatory establishment and product licenses required for Topcon Canada Inc. (TCI).

CORE JOB DUTIES

• Execute the current pharmaceutical and medical device quality management systems and ensure all personnel within TCI are trained and follow procedures.

• Oversee quality inspection activities for inbound finished goods, review and approve product dispositions.

• Lead non-conformance, complaint handling and change management.

• Acts as the Management Representative for the quality assurance system on behalf of TCI with the regulatory agencies and customer quality affiliates.

• Liaise with Topcon RA/QA shared services and lead the integration of the global quality management system into TCI.

• Official correspondent with Health Canada on behalf of TCI.

• Owns the annual establishment license renewal process for the pharmaceutical and medical device licenses.

• Supports Topcon Headquarters and other suppliers for initial and renewed medical device licenses for class 2 products and above.

• Authors and implements standard operating procedures and work instructions for RA/QA.

• Reviews product labeling and marketing collateral intended for the Canadian market.

• Performs vigilance reporting on product complaints and market actions such as product recall, as required.

• Acts as the lead to represent TCI for all regulatory and customer audits.

• Supports TCI in all other regulatory matters as appropriate.

Education & Experience

• Minimum of a Bachelor’s degree in life sciences or medical technologies.

Knowledge, Skills & Attributes

• Must have excellent communication skills in both French and English, both written and oral.

• Industry recognized certification (i.e., RAC certification) preferred.

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