About the job

Legal.io is working with a leading medical technology company to bring on an experienced Medical Device Regulation Paralegal. In the role you will assist attorneys with compliance related to medical devices, specifically in the Medical Device Labeling space. The position is a remote contract role for 6 months.

What You'll Do:

Review promotional and advertising labeling

Spot FTC and FDA-related issues, such as whether a particular piece is fair and balanced and not misleading.

Review labels for product liability issues, such as failure to warn.

Conduct legal research related to medical device regulations

Draft and review regulatory submissions, such as 510(k) applications and premarket approval (PMA) applications

Assist with compliance audits and inspections

Draft and review contracts and agreements related to medical device regulation

Maintain and organize regulatory documents and records

Communicate with regulatory agencies and other stakeholders, such as healthcare providers and patients, regarding regulatory compliance issues

Who You Are:

Possess a strong understanding of medical device regulations, such as the Federal Food, Drug, and Cosmetic Act (FDCA), the Medical Device Regulation (MDR) in the European Union, and other international regulations.

Work experience in the fields of orthopedics, life sciences, pharmaceuticals or medical devices.

Ideal candidate would have a paralegal certificate or associate's degree in paralegal studies, as well as experience in medical device regulation.

Job Details:

Start Date: Immediate

Duration: 6 months

Location: Remote

Benefits: Medical, vision, dental, 401k

Pay: $120,000 - $140,000 annualized