Regulatory Affairs and Quality Assurance Associate

Regulatory Affairs and Quality Assurance Associate

Join Device Technologies as a Regulatory Affairs and Quality Assurance Associate . We are seeking a detail-oriented professional with a strong background in compliance and product registrations. In this dynamic role, you\'ll help ensure our medical technologies meet the highest regulatory and quality standards. If you\'re ready to make a meaningful impact in healthcare, apply now and become part of a team dedicated to advancing patient outcomes.

Key Responsibilities

• Regulatory Affairs
• Collaborate with RAQA Management and Business Management to ensure effective and timely regulatory applications in the target region.
• Assess requirements for allocated product or product range to ensure complete regulatory compliance in the target region.
• Liaise with both local and overseas suppliers / manufacturers on regulatory issues and to obtain required documentation for regulatory compliance and new applications.
• Prepare and lodge regulatory applications in relevant regions.
• Develop and maintain excellent working relationships with relevant regulatory bodies including various government departments.
• Maintain all regulatory technical files, databases, spreadsheets, and internal registers for allocated product ranges.
• Ensure accuracy and currency of data held on all databases (SAP, the Hub, etc.) for allocated product ranges.
• Collaborate with Business Management and Sales teams to provide relevant regulatory information as required for tenders, quotations, customer requirements, product launches, and principal meetings.
• Investigate and resolve quarantined non-conforming product according to internal quality procedures.
• Review and process internal new product requests and marketing materials according to internal quality procedures.
• Assist with all mandatory reporting requirements for recalls, adverse incidents, and other issues, as directed.
• Assist with QMS responsibilities in region including process documentation, auditing of internal processes, training, participation in external audits
• Product Complaints & Post Market
• Administer the Product Complaint system, including maintaining accurate and up-to-date records of all complaints.
• Liaise with overseas suppliers, customers, sales team, and internal staff to obtain effective and timely outcomes.
• Investigate complaints, ensuring accuracy and completeness of information prior to recording.
• Notify complaints to relevant manufacturer and Regulatory Affairs, coordinate assessment of event reportability and notification to authorities as required.
• Ensure effective follow-up on completed complaints, including provision of replacement product and / or credit, follow-up letter to customer, etc.
• Regular reporting to RA management as required; collate product complaints information for annual reporting.
• Present Product Complaints process to new employees during company inductions.
• Understand and communicate Adverse Events (AE) and / or Field Safety Corrective Actions (FSCA) to country RAs in the region.
• Ensure AE and FSCA are executed in a timely manner and documents are in place and closed.

About you

At Device Technologies, we succeed through our commitment to five key values :

Our ideal candidate for this role aligns with these values.

Experience required :

Interested?

To apply for this opportunity, please click on the \'apply\' button to be redirected to our candidate application portal.

At Device Technologies we are motivated by the opportunity our equipment provides to change people’s lives. We have a clear vision to ensure all our people feel valued and respected, can be themselves and can flourish as contributors to the success of our business.

Our promise is all qualified applicants will receive consideration for employment without regard to diversity of race, gender, sexual orientation, religion, ethnicity, disability, age and all the other wonderful characteristics that make us different.

Seniority level

Not Applicable

Employment type

Full-time

Job function

Quality Assurance and Administrative

Industries

Medical Equipment Manufacturing and Hospitals and Health Care

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