Compliance Specialist at Medtronic

Lafayette, Colorado, United States

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor's degree required
Minimum of 2 years of relevant experience, or a Master's degree with 0 years of relevant experience
Relevant experience in a Design & Development and/or Manufacturing setting (nice to have)
Experience supporting and/or participating in regulatory inspections and audits (nice to have)
Demonstrated knowledge of all quality system elements and regulatory requirements (i.e. FDA, GMP, QSR, ISO 13485, and MDSAP) for finished medical devices with the ability to effectively implement and communicate those requirements in a government regulated healthcare industry. Special focus on Core QMS, Design Control & Manufacturing processes/requirements (nice to have)
Effective usage of data analysis tools, analytical and research skills, and problem-solving techniques with keen attention to detail and simultaneous understanding of the "big picture". Desire to follow an audit trail to identify risks, non-conformances, true root cause, etc. (nice to have)
Outstanding written, oral communication, and presentation skills (nice to have)
Sound judgement, ability to make decisions, work independently, and demonstrated leadership skills (nice to have)
Ability to manage and execute on multiple critical projects simultaneously. Capable to manage multiple priorities and escalate issues (nice to have)
Ability to be independently mobile, interact with a computer, and communicate with peers and co-workers (for office roles)

Responsibilities

Develops, implements, administers and certifies compliance policies, procedures, and practices
Ensures alignment with legal and ethical standards of the organization
Provides compliance advice, investigates complaints and verifies deficiencies are corrected
Develops employee communication and training programs that focus on the elements of a companywide compliance program
Enforces anti-bribery and anti-competition laws
Analyzes metrics and audits functional compliance program
Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program

Skills

Compliance Policies

Regulatory Inspections

FDA

GMP

QSR

ISO 13485

MDSAP

QMS

Design Control

Manufacturing Processes

Data Analysis

Audits

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.

Land your dream remote job 3x faster with AI

Try Jobo Free