Quality Assurance / Regulatory Affairs Associate

About the Role:

Nipro Canada, a manufacturer and distributor of disposable medical devices located in Lindsay, Ontario, is currently seeking a proactive and accountable individual with strong problem-solving and organizational skills for the position of Quality Assurance (QA)/Regulatory Affairs (RA) Associate in daily routine operations. The desired candidate must have a minimum of 3-5 years working experience in Quality Assurance in the medical device industry.

Job Responsibilities: Reporting to QA/RA Director, the role of QA/RA Associate is required to:

  • Monitor conformance to GMP under Quality System guidelines, compliance with ISO standards and adherence to organizational health/safety policies in the operational processes on a daily basis
  • Monitor the implementation of Standard Operation Procedure (SOP) and update the SOPs in collaboration with other functional departments as needed
  • Monitor and control materials and equipment such as returned product, packaging materials, sterilization supplies, environmental control supplies, supplies for testing and process validation, manufacturing equipment, sterilization equipment, and other calibration tools
  • Ensure full documentation on QA related issue throughout the operational procedure and full communication with all functional stakeholders
  • Work closely with R&D in identifying the needs of validation and perform the testing on operation process, materials or manufacturing equipment as needed.
  • Maintain and update documents such as QA files, QC inspection records, production batch records, sterilization records, validation documentation, supplier notification, internal change notification, customer complaint history, and testing/validation reports
  • Participate and support documentation for the regulatory audit, internal audit, management reviews, and supplier evaluation meetings Support and prepare QA compliance documentation for export and other customer inquiries
  • Perform other QA duties as required
  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies and advise on the submission strategy
  • Timely compile materials for license renewals, updates and registrations, responsible for timely registration of the facility
  • Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
  • Review labeling and labels for compliance with regulatory requirements
  • Provide the regulatory reviews of customer complaints and define the regulatory reportability
  • Maintain current knowledge of HC, FDA and international regulation, guidance and standards applicable to company products
  • Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes.
  • Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required
  • Other related duties as assigned

Qualifications:

  • Minimum progressive 3 years of QA/RA working experience in medical device manufacturing industry
  • University Degree/College Diploma in Biomedical engineering or science or QA/RA related field
  • Demonstrated experience in ISO9001 and internal QA audit
  • Expertise in ISO13485, HC, FDA, and EU MDR 2017/745 are preferred
  • Experience with regulatory submission in jurisdictions like HC, FDA etc.
  • Advanced computer skills with Microsoft Office Suite

Required Skills:

  • Excellent verbal and written communication skills, especially report writing skills
  • Strong organization and time management skills
  • Result-oriented, experienced QA professional that is audit-ready
  • Self-starter and effective learner
  • Excellent understanding of environment control parameter, engineering drawing, and configuration, regulatory procedures
  • Must be detail-orientated, problem-solving and analytical
  • Must be able to work both independently and in a team environment
  • Previous experience with sterilization equipment is highly preferred
  • Proven Ability to multitask and maintain procedure integrity
  • Demonstrated Ability to follow and enforce procedures
  • High level of math skills
  • Ability to identify and suggest continuous improvement
  • Positive attitude towards changes
  • Ability to work under pressure and other intense deadlines

We thank all who applied. Only selected candidate will be contacted for interviews

Nipro Canada provides equal opportunity to all applicants. Accommodations for individuals with disabilities will be provided upon request at any stage of the recruitment and selection process.

We thank all who apply for the job; however, only selected candidates will be contacted for the interview.

Please send your application (Resume and Covering letter) via our indeed posting: Here.