Regulatory Affairs/QA Co-ordinator

Ref. no.: MK/36140/IJP

Tags: Regulatory Affairs QA Co-ordinator Roscommon QA Co-ordinator Regulatory Affairs QA Co-ordinator Regulatory Affairs Regulatory Affairs QA Co-ordinator WestMeath Regulatory Affairs Coordinator Regulatory Affairs/QA Co-ordinator

Location(s): Roscommon Westmeath

Salary range (€): Negotiable

Additional benefits:

Minimum experience required: 2 - 3 Years

Employment type: Permanent Full-time

Minimum qualification: Third Level Degree

Contact person: Michelle Kilcar

Contact e-mail: michelle@ccprecruit.ie

Job description:
Regulatory Affairs/QA Co-ordinator

Under the direction of the Manager, Regulatory Affairs EMEA and Manager, Product Performance Group document reports of product performance issues, prepare and communicate investigational findings to appropriate individuals and groups.

For all European product performance issues, assess and document Vigilance reportability, prepare and submit Vigilance reports in line with mandatory reporting timelines. Co-ordinate all field based activities relating to recalls and safety alerts. Respond to communications with European Regulatory Authorities where required.

Responsiblities

• Receive, document, and investigate reports of product performance issues within EMEA, including those relating to EMEA distribution contracts. Investigation includes the ability to appropriately communicate with reporting sales organization and clinicians to discuss and understand details of their clinical experience.
• Immediately notify appropriate internal Arrow functions of issues that suggest a potential regulatory or business risk. This requires the understanding of how to identify such a risk and knowledge of how it will affect various internal groups. Internal contacts must be developed to ensure that information is appropriately disseminated to compel appropriate and timely response.
• Liaise with defined country contacts to ensure compliance with the EMEA Post Market Surveillance and complaint handling process.
• Assist the Product Performance group with EMEA complaints including defining the feedback requirements for individual customers.
• Review with the reporting Arrow representative the evaluation reports and letters received from the US to ensure all relevant customer concerns are addressed.
• Follow up on outstanding evaluations to ensure timeliness and regulatory compliance.
• Maintain the Complaint Management System for EMEA complaints. Provide country managers, regional managers and product managers with the monthly status reports on relevant product complaints. Also provide updates on EMEA product complaints for EMEA Management Review meetings.
• Screen customer inquiries, answer product questions where appropriate, and refer complex clinical/technical questions to the appropriate Arrow personnel. Extensive product/clinical function knowledge is required, as well as a thorough understanding of the function of Arrow's internal departments to compel effective customer response.
• Respond to specific product complaint or vigilance report questions from the EMEA Competent Authorities liaising with PPG. Assist with Vigilance Reporting (review and assist with all reporting and follow-up for the European Competent Authorities
• Coordinate product recall communication to subs/distributors, where applicable, and regulatory authorities
• Perform Post Market Surveillance and complaint handling training for new employee and annual complaint handling training
• Measure customer satisfaction for complaint handling process
• Adhere to all Company policies, rules, procedures and housekeeping standards.

Education

Minimum of Bachelor Degree in health-related field, life sciences, engineering. or quality assurance/regulatory affairs is highly desired. Substitution with comprehensive knowledge of Arrow products, their functionality and clinical use, relationship of Arrow internal functions, and an understanding of quality and regulatory requirements will be considered.

Experience

Minimum of 2 years Quality Assurance or Regulatory Affairs experience in the Medical Devices industry or associated area. Preferably experience in Vigilance reporting and communication with Regulatory Authorities.


Other Qualifications

• Good analytical skills, strong technical report writing and a customer oriented approach to work required.
• Ability to innovatively search for solutions to complex technical and procedural problems.
• Ability to manage relationships with international regulatory agencies
• Capacity to communicate Post Market Surveillance and Vigilance regulatory requirements to field based and internal employees
• Ability to read analyze and interpret data and review product evaluations
• Fluency in English(business proficiency).