Associate MDR / Vigilance Specialist

GAL Medtronic Vascular Galway Unlimited Company; Parkmore; On-site; EUR 40,000 - 60,000; Full time

Job summary

Medtronic Galway is seeking an Associate MDR/Vigilance Specialist to document and evaluate product feedback and analysis for Medtronic products, determining complaint status and regulatory reporting in line with US and OUS guidelines.

You will compile regulatory agency reports and, as part of complaint closure, ensure timely reviews of product feedback, investigations, and follow-up actions, contributing to post-market vigilance.

Qualifications

• Bachelors / Level 8 Degree with a minimum of 0 years experience.
• 1+ years of MDR experience preferred.
• Degree in Health Care, Sciences, or Bio-Medical Engineering Science, Engineering or related discipline is preferred.
• Medical device industry experience is advantageous.
• Strong verbal and written communication skills.
• Knowledge of basic anatomy and physiology.
• High level of computer proficiency (Microsoft Office, SAP, Siebel, Oracle Clinical, etc.).

Responsibilities

• Apply policies and procedures to comply with FDA and OUS regulations.
• Monitor the company's drug or medical devices surveillance program including intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
• Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
• Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs) and Vigilance Reports (VR) as required by regulatory agencies.
• Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
• Maintain awareness of new products, government regulations and requirements.
• Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Other duties as assigned.

Skills

Verbal & written communication

Anatomy & physiology knowledge

Attention to detail

Computer proficiency

Education

Bachelor / Level 8 Degree

Health Care / Sciences / Bio-Medical Engineering degree

Tools

Microsoft Office

SAP

Siebel

Oracle Clinical

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life At our Customer Quality and Experience Management (CQXM) group, which is part of the Galway CQXM Complaint Handling and Regulatory Reporting Department in Medtronic plc, we focus on complaint handling and post market regulatory reporting activities for a wide range of Medtronic products. You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance. In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for Medtronic products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure this individual performs activities to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure. Come for a job, stay for a career!

A Day in The Life Of:

Responsibilities may include the following and other duties may be assigned.

• Apply policies and procedures to comply with FDA and OUS regulations.
• Monitor the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
• Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
• Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs) and Vigilance Reports (VR) as required by regulatory agencies.
• Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
• Maintain awareness of new products, government regulations and requirements.
• Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Other duties as assigned.

Key Skills & Experience

• Bachelors / Level 8 Degree with a minimum of 0 years experience.
• 1+ years of experience in MDR role is preferred.
• Degree in in Health Care, Sciences, or Bio-Medical Engineering Science, Engineering or related discipline is preferred.
• Medical device industry experience is advantageous.
• Strong verbal and written communication skills.
• Knowledge of basic anatomy and physiology.
• Strong attention to detail.
• High level of computer proficiency (Microsoft Office, SAP, Siebel, Oracle Clinical, etc.).

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offer a competitive salary and flexible Benefits Package

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 40,000.00 EUR - 60,000.00 EUR | This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.