Our client is a global manufacturer of Medical equipment, a leader in their Industry.
- Full-time- permanent role with a stable organization
- Work from home and also office in Mississauga
- New position due to growth!
- Benefits from Day 1 (no deductions from employee – 100% company paid)
- Medical, Dental, RRSP - up to 6% match
- Extended health care - Physiotherapist, Chiropractic etc. - $500 per practitioner!
- Hours: 8:30am – 5:00pm
The Regulatory Affairs Specialist is responsible for the preparation and on time filing of primarily class 2 and class 3 devices, responding to AI requests, preparing responses to agency questions. In addition, the role is responsible for reviewing the portfolio of products to ensure proper management from a Regulatory perspective. The role will work closely with Quality on complaints, recalls and mandatory reporting. The position communicates with internal customers, global corporate partners, and external regulatory bodies.
- Complete regulatory assessments for change control and testing activities, as well as participating in and completing reviews of the proposed change(s), reason(s) for change(s), impact assessment(s) and disposition(s) of affected items(s).
- Provide regulatory review for deviations, non-conforming material, corrective and preventive action (CAPA), complaints, event reporting, and recall-related activities.
- Preparation of Health Canada regulatory submissions for registration of medical devices (entire product registration package, including amendments and responding to AIs)
- Maintain collaborative relationships with research, product development, quality, operations, and clinical departments.
- Maintain current and in-depth knowledge of Health Canada and FDA/worldwide regulatory requirements, policies and other critically important information (e.g., Health Canada guidance documents) that may affect the company's products and its customers.
- Participating and completing reviews of identified issue(s), containment(s), root cause(s), establishing and implementation of corrective action(s) and effectiveness assessment(s), as appropriate.
- Serves as regulatory representative to marketing, research teams and regulatory agencies.
- As needed, monitor appropriate regulatory agency activities in areas of interest to the company.
- As needed, maintain and/or update existing regulatory authorizations, including updates and reviews of clinical evaluation reports, technical files, and annual reports for clinical studies and marketing applications.
- Complete and support other tasks which may be assigned from time-to-time by management.
- Completion of a university undergraduate degree, preferably in life sciences.
- Diploma or certificate in Regulatory Affairs preferred
- 2-5 years’ regulatory experience in the Medical Device industry
- In-depth knowledge of Canadian Medical Devices Regulations and Guidelines for licenses of Medical device products. Experience/knowledge of FDA requirements is considered an asset.
- Very effective command skills and communication ability, verbal and written, professional with ability to develop strong long term relationships.
- Experience collaborating with international product registrations is a strong asset.
- Strong attention to detail and ability to think analytically.
- Ability to work with a sense of urgency, prioritize work, meet objective / deadlines with strong organizational capability.
- Excellent communication skills (verbal and written) as this role will be collaborating with internal teams.
- Strong Excel, Word skills; project management is an asset.