Assess device related complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely manner. Handle recalls and field actions, if required. Review and approve complaint files.
Maintain eQMS system and all document control activities
Support external audits (e.g. customer, corporate, notified body)
Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, and supplier questionnaires
Perform change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners
Support the execution of the site's training program
Maintain Quality records according to Exelint International policies and procedures
Support timely delivery of products to customers with lot release and preparation of certificates of analysis
Support external regulatory agency audits, providing input to minimize potential for findings of non-compliance.
Participate in post-market surveillance activities for licensed products.
Assist in fulfilling requirements under the EU MDR 2017/745 transition.
Maintain QMS procedures related to regulatory responsibilities, product licensing, and regulatory reporting.
Lead projects as needed by the quality department and participate in design control projects
Participate in internal audit program.
Other projects will be assigned as various business needs arise
Education
Bachelor’s degree or country equivalent in Engineering, Science, related scientific discipline, or equivalent.
Higher degree will be an advantage
Certifications
CQA, GMP certifications preferred
Experience, Skills And Technical Knowledge
Minimum of 2 years regulatory or equivalent experience within a medical device organization
Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.)
Prior experience with eQMS (Qualio, Greenlight Guru, etc…)
Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills
Excellent written and Verbal communication skills with the ability to listen, articulate and advocate
Proactive, high performance, result oriented and manage projects with ethical integrity
Technical system skills (e.g. MS office applications, databases, efficient online research)
Manage multiple projects and deadlines
Ability to identify compliance risks and escalate when necessary
Demonstrate both creative and critical thinking skills
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Staffing and Recruiting
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