Data Analyst - Medical Device Regulatory - EU MDR / EUDAMED (Remote)

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Data Analyst - Medical Device Regulatory - EU MDR / EUDAMED (Remote) on a contract basis to support our Customer's business needs. This role is remote, however, preference would be given to candidates who are based out of California.

Responsibilities:

• Has in-depth understanding of EUDAMED process and data

• Facilitate cross-functional discussions with Subject Matter Experts (SMEs)

• Background in life sciences or medical device industry

• Past experience in business analyst roles

• Familiarity with test script authoring, IT2/UAT and validation deliverables

• Managing stakeholder expectations

• Collection of data from various sources (documents, software systems, etc.)

• Experience in registration of UDI-DI devices

• Knowledge of XML generation and/or submission

• Ability to resolve XML validation errors

• Familiarity with EDW or Tableau

• Adaptability: Ability to quickly adjust to new technologies, workflows, and environments.

• Strong project management and problem-solving skills

• Communication: Excellent communication skills, both verbal and written.

• Provide training, documentation, and user guidance for internal stakeholders.

• Ensure compliance with applicable regulations (e.g., 21 CFR Part 11, GxP).

Requirements:

Strong Experience with EU MDR & EUDAMED

• Proven understanding of European medical device regulations and EUDAMED data requirements is essential, especially for product registration and compliance projects.

Regulatory & Data Analysis Hybrid Skill Set

• Ability to act as both a regulatory analyst (understanding compliance frameworks) and a data analyst (working with data extraction, validation, and loading into tools/templates).

Medical Device Industry Background

• Prior experience in the medical device or pharmaceutical industry, with knowledge of regulatory systems and terminology specific to device registration workflows.

Hands-On Data Validation & Tool Familiarity

• Demonstrated skill in identifying data sources, performing data validation, and working with validation tools/templates - ideally with minimal supervision.

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.