Associate Regulatory Affairs Specialist at Medtronic

Watford, England, United Kingdom

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Medical Technology, HealthcareIndustries

Requirements

Degree in Engineering, Life-science, Biology or another relevant advanced degree OR 3-5 years of medical device regulatory experience
Advanced computer skills (Microsoft Office including advanced Excel skills and ability to use custom organizational software)
Critical Thinking and problem solving
Autonomy and proactivity, continuous learning, attention to detail
Organizational and strong administrative skills, including self-organisation and task tracking
Clear communication, proficient English language to allow for stakeholder management and influencing
Quality orientation and patient safety focused, curiosity and high interest in the medical device field

Responsibilities

Preparation, execution and follow up of FSCA (field safety corrective actions) according to the enterprise plan
Close collaboration with the sales managers and sales representatives to collect/record evidence, allowing timely closure of the UK/Ireland Field Actions
Reconciliation activities in collaboration with the FCA Support Team
Follow up on inquiries from the Competent Authority to i.e., Field Action or Vigilance activities, including updating the Medtronic reporting systems and record keeping
Support on Post-Market Surveillance - provide advice to sales team members on product complaint handling processes and returns, to assure compliance to UK/Ireland Regulations and Medtronic procedures
Monitors the shared mailbox by providing support to tender requests, customer requests, internal stakeholder requests
Sourcing, verifying and providing regulatory documents to customers and other stakeholders
Connecting requests to the appropriate Organizational Unit and ensuring complete follow up
Maintaining training completion, participation in team and process improvement initiatives

Skills

Regulatory Affairs

Field Safety Corrective Actions

Post-Market Surveillance

Vigilance Activities

Complaint Handling

Competent Authority Requests

Product Documentation

Record Keeping

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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