Senior Regulatory Affairs Manager - Mervue at Medtronic

Galway, County Galway, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Level 8 Degree in Scientific or Engineering field with a minimum 7 years’ experience in regulatory affairs for medical devices, of which 5+ years had leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
Or an advanced degree with a minimum of 5+ years’ experience in regulatory affairs for medical devices with 5+ years leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
Experience in a regulatory affairs leadership role, with a record of managing teams and supporting departmental goals
Strong knowledge of the global regulatory landscape and experience interacting with regulatory bodies
Experience supporting medical devices from concept to market, including post-market activities
Understanding of business operations and financial considerations within a regulated environment
Proven ability to support process improvements and change management initiatives
Ability to use data and analytics to support decision-making and communicate regulatory requirements
Excellent communication and interpersonal skills

Responsibilities

Support the development and implementation of global regulatory strategies throughout the product lifecycle, from R&D through commercialization and post-market activities
Collaborate with cross-functional teams to ensure regulatory requirements are incorporated into development plans and timelines
Provide regulatory guidance on product submissions (e.g., 510(k), etc.)
Oversee the preparation, review and submission of regulatory filings in the US and EU
Liaise with regulatory bodies (e.g., FDA, Notified Body) to facilitate product approvals and resolve regulatory issues as needed
Manage resources across assigned product programs, aligning activities with departmental priorities
Support team structure, talent development, and professional growth of regulatory staff
Mentor and coach team members to build regulatory expertise
Identify potential regulatory risks and contribute to the development of mitigation strategies
Stay informed on evolving regulatory trends and changes, providing timely guidance to teams
Participate in business initiatives by providing regulatory input and supporting due diligence for new ventures and partnerships
Occasionally represent the company in discussions with regulatory bodies and industry groups

Skills

Regulatory Affairs

510(k)

FDA

Notified Body

Regulatory Submissions

Regulatory Strategy

Product Lifecycle Management

Cross-functional Collaboration

R&D

Clinical

Operations

Marketing

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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