Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

As a member of our Regulatory Affairs team, you will proactively drive launch of new products in markets/geographies through Regulatory expertise and support marketing and product development initiatives by providing strategic global regulatory guidance.

 

RESPONSIBILITIES INCLUDE:

STRATEGY

  • Develop international strategies for regulatory approval of medical devices through regulatory/product competitive research and insights
  • Drive clarity on risks and methods to overcome them to have market centric products in the shortest possible time

REGULATORY SUBMISSIONS

  • Lead regulatory submissions, including filing and/or creation of Dossiers, 510(k) Submissions, Applications, Change Notifications, and other country-specific product registrations
  • Prepare robust regulatory applications with right claims to achieve high yield with strategy to accelerate product launch success

REGULATORY PROCESSES

  • Maintain ongoing surveillance, analysis, and dissemination of all relevant international medical device regulations to ensure regulatory compliance is maintained and internal parties are appropriately informed
  • Support the product release process by reviewing and approving requests for product release
  • Conduct reviews of product and manufacturing changes for compliance with applicable regulations and determine regulatory impact

RELATIONSHIP MANAGEMENT

  • Interface directly with regulatory agencies as the need arises and build strong relationships
  • Provide the voice of international regulatory affairs on project planning and cross-functional project teams and drive clarity for market access in the shortest time period with claims strategy
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Support regulatory, customer and internal audits

COMPLIANCE

  • Comply with Company policies, operating procedures, and processes

HEALTH AND SAFETY

  • Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.

QUALIFICATIONS

  • Degree in health or biological sciences, or a related field
  • Certificate in Regulatory Affairs or equivalent work experience
  • Minimum of 5 years of regulatory experience in a medical device environment
  • Brought to market at least five medical devices globally
  • Knowledge and understanding of regulations governing medical devices in Canada, US and Europe is an asset
  • Knowledge of the requirements of an ISO 13485 quality program
  • Excellent oral and written communication skills, including technical writing
  • Computer literate with:
    • Advanced experience in a Windows environment
    • Advanced experience in MS Word
    • Advanced experience in MS Excel
    • Basic knowledge of Enterprise Resource Planning (ERP) software, e.g. Great Plains Dynamics is and asset
  • Experience using database software to manage data and records is an asset
  • Strong organizational and general administrative skills
  • Demonstrated attention to detail
  • Strong interpersonal skills with ability to communicate effectively with internal personnel and external parties, e.g. customers

 

How to Apply

Email
hr [at] trudellmed.com

  • Include a résumé and cover letter which includes the job title
  • Use Microsoft Word .doc or .rtf formats
  • Include the job title and your name in the title of both Word documents
  • Include the job title in the Subject line of your email

Mail
Human Resources
Trudell Medical International
London, ON  N5V 5G4
Canada

 


 

At the applicants's request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.

Please send your résumé only once per position.

Résumés will be accepted throughout the process, but only candidates selected for interviews will be contacted.

TMI is an equal opportunity employer.

We thank all applicants in advance for their interest in joining our team.