Regulatory Affairs Associate/specialist

Coltene SciCan is a market leader in the manufacture and distribution of dental and medical equipment. Coltene-SciCan’s manufactured sterilization and disinfection equipment is sold in over 80 countries, worldwide. Coltene-SciCan is located in Toronto near the intersection of Highways 401 and 404 (Don Mills and York Mills). It is accessible by public transportation.

We currently have an opening for a 1 year contract Regulatory Affairs Associate/Specialist position. Reporting to the Director of Regulatory Affairs, this position assists in assuring compliance to the regulatory requirements pertaining to the manufacture, importation, and sale of SciCan products in Canada, the U.S., and Internationally. In cooperation with the Director of Regulatory Affairs, the Regulatory Affairs Specialist will assist in the establishment and maintenance of systems and data bases to achieve compliance and uninterrupted sale of products to SciCan customers. This position will also work closely with other SciCan functions including R&D, Quality Assurance, and Marketing to assist in implementing shared objectives and to achieve gains in continuous improvement.

**Core Competencies**:

- Sound national and international regulatory knowledge
- Superior analytical, organizational and independent problem-solving skills
- Excellent oral communication and writing skills
- Attention to detail
- Ethics and integrity
- Computer literacy
- Good interpersonal skills
- Proactive
- Problem solving with multiple priorities
- Organization skills
- Decision making / good judgement
- Results driven
- Team oriented
- Adaptable / Flexible
- Development and continual learning

**Job Duties & Responsibilities**:

- To assist the Director Regulatory Affairs in the establishment of systems and databases to maintain compliance to national and international regulatory requirements;
- To support product label / packaging development;
- To assist in maintaining practices that comply with the importation, testing, registration, and post sale traceability and reporting requirements for SciCan products;
- To provide support to the R&D Department in order to ensure compliance with SciCan manufactured product. Compliance will encompass direction of regulatory registrations, product safety testing, and testing house audit reports & data files;
- To provide guidance to the R&D, Quality and the SciCan manufacturing facilities with the appropriate GMP requirements, Standards, & Guidelines applicable to the SciCan production sites;
- To act in a supportive role for the Business Unit and Sales regarding regulatory needs particular to imported product for distribution purposes;
- To assist in the monitoring of all incoming reports which may be of an “adverse incident” nature;
- To support audit / inspection requirements relating to the Regulatory Affairs department;
- To assist the Director of Regulatory Affairs in the execution of recall procedures, as required.

**Educational and Experience Requirements**:

- A graduate degree in a science or health discipline or a graduate of a community college program in a related field with equivalent work experience;
- Minimum 2 years experience in a multi-division work environment within the healthcare industry;
- Superior analytical, organizational and independent problem-solving capabilities;
- Computer literacy in Adobe Acrobat, Windows, Excel, MS Office
- Excellent verbal, composition and written communication skills
- Good interpersonal skills as this function interfaces with various departments as well as external customers, suppliers and Regulatory Authorities
- This position reports to the Director of Regulatory Affairs

**Job Type**: Fixed term contract
Contract length: 12 months

**Benefits**:

- Casual dress
- Company events
- Discounted or free food
- Wellness program

Schedule:

- 8 hour shift
- Monday to Friday

Ability to commute/relocate:

- North York, ON: reliably commute or plan to relocate before starting work (required)

Application question(s):

- Are you legally eligible to work in

Canada?