Senior Regulatory Affairs Specialist at Medtronic

North Haven, Connecticut, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor's degree with 4+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry OR a Master's degree with 2+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry

Responsibilities

Provide strategic and technical regulatory guidance to support design and manufacturing sustaining covering both domestic and international requirements
Prepare 510(k) submissions, change notices and updates to technical documents to support CE marking and other global product registrations as necessary
Interact and negotiate with regulatory authorities during product development and review processes
Share business and product information with international regulatory teams to inform strategy and communicate requirements to the business team
Manage multiple projects, prioritize daily tasks, and ensure project deadlines are met
Collaborate with engineering, quality, clinical, marketing, and other departments to fulfill regulatory responsibilities
Review and approve promotional and advertising materials for compliance
Stay up-to-date on domestic and international regulatory requirements, guidelines, and standards
Participate in internal and external audits as required
Maintain regulatory documentation to ensure compliance
Coordinate and prepare document packages for regulatory submissions, audits, and inspections
Lead or compile materials for submissions, license renewals, and annual registrations
Monitor regulatory procedures and changes
Interact directly with regulatory agencies on defined matters as needed
Contribute to continuous improvement initiatives and process optimization within RA
Perform additional duties as assigned

Skills

510(k) submissions

CE marking

EU MDR

Regulatory affairs

Medical devices

Technical files

Regulatory change assessments

Advertising review

Promotional materials review

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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