QA/RA Quality and Regulatory and Compliance Specialist, (QA/RA) Medical Devices
This position is responsible for managing the day to day activities of Client Outlook’s Regulatory Registration and Compliance activities. This position will also help in the creation, enhancement and maintenance of procedures in accordance with relevant regulations and industry guidelines.
- Provide strategies to maintain applicable regulatory compliance in various business areas and compliance to any other specific, established, guidelines or policies at a Global Level
- Identify compliance risks, detecting shortcomings and bringing to the attention of manager;
- Maintain regular contact with manager on matters relating to quality/compliance issues;
- Remain up to date with new ideas, concepts, guidelines and regulations for medical devices in the global market
- Continuously monitor the changing regulatory landscape to develop, implement, monitor and assess strategic initiatives for the department and organization in the area of regulations
- Maintain and initiate registration of product in global markets
- Participate in External Audits, and management of CAPA items
- Assist with Patient Safety evaluations, and Health Hazard Evaluations.
- Conduct Internal Audits
- Coordinate Post-Market Surveillance and Vigilance activities
- QMS maintenance, maintain inspection ready state
- Working with internal and external teams to coordinate content gathering for Privacy and Security compliance with FDA, ISO and NIST protocols
- Complete Supplier questionnaires regarding to regulatory, QMS, Privacy and Security
- Other duties as determined that will support the business and further develop your skill set
- 4+ years regulatory compliance experience in a similar environment/industry at a global level
- Experience with ISO 13485 and all other relevant industry guidelines, policies and regulations
- Experience in moving into new global markets/determining registration and regulatory requirements
- Previous experience with QA processes in a medical device environment;
- Experience with FDA and Health Canada inspections/audits, MDSAP
- Proven record of client focused problem solving and relationship management
- University degree or equivalent experience
- Regulatory industry knowledge for Medical Devices is required
- ISO 13485:2016 knowledge is required, Experience with ISO 27001, 62304, 62366 would be asset
- RAPS certification or enrollment would be an asset
- Internal Auditor certification would be helpful
- proficient in researching and retaining complicated compliance knowledge
Client Outlook offers:
A rewarding career for outstanding professionals and a collaborative and inclusive culture, with flexible practices that focus on our people's well-being. We provide a comprehensive variety of resources to support your health and well-being needs, with benefits, competitive compensation, and recognition to help sustain your efforts in making an impact that matters.
We are also in compliance withthe Accessibility for Ontarians with Disabilities Act 2005 (AODA) and if you require a disability related accommodation in order to participate in the recruitment process, please contact us via email at firstname.lastname@example.org , to provide your contact information. The HR staff will contact you within 48 hours.
We thank you for your interest, only those selected for further screening or an interview will be contacted.