Job Details

Regulatory Affairs Specialist

Title
Regulatory Affairs Specialist
Length
Full Time
Salary
not disclosed
Employer

SciCan

Location
Toronto
Ontario
Date Posted
06/12/2017 - 11:00
Closing Date
06/01/2018 - 11:00
Job Description
Summary: 

We currently have an opening within the Regulatory Affairs team for a Regulatory Affairs Specialist to join our growing, and well-established company. 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 databases 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.  

Education & Qualifications: 
  • 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 5 years of experience in a multi-division work environment within the healthcare industry;
  • Knowledge and application of national and international regulatory requirements for medical devices and drugs;
  • Knowledge and application of procedures, quality systems, and the ISO 13485 standard;
  • 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.
Duties & Responsibilities: 
  • To assist the Director of Regulatory Affairs in the establishment of systems and databases to maintain compliance to national and international regulatory requirements;
  • To assist the Director of Regulatory Affairs with the coordination of submissions for new/existing product applications for regulatory compliance;
  • 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 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 particularly 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.
Skills & Competencies: 

Core Competencies: 

  • Communication;
  • Attention to detail;
  • Ethics and integrity;
  • Computer literacy;
  • Interpersonal skills;
  • Problem Solving;
  • Organization;
  • Decision making;
  • Results driven;
  • Team oriented;
  • Adaptability and Flexibility;
  • Development and Continual Learning.
Other Information: 

Compensation: 
We offer a competitive salary with comprehensive benefits package. 

Submitting Applications: 
Interested candidates, please e-mail a copy of your resume to hr@scican.com.  Candidates that meet the above requirements will be contacted for an interview.  We would like to thank all candidates for their interest in SciCan.  No phone calls please. 

SciCan is committed to accommodating applicants with disabilities throughout the hiring process, in accordance with the Accessibility for Ontarians with Disabilities Act (AODA). Our Human Resources team is responsible for working with applicants requesting accommodation any stage of the hiring process.