Responsible for coordinating product labeling updates to meet MDR requirements, ensuring timely completion and alignment with project deliverables.

Qualifications:

Located in the Boulder, Colorado area and available to be on-site 3 days per week in the Lafayette office

Bachelor's degree required

1-3 years of experience in project coordination, preferably in the medical device industry

Strong organizational skills with attention to detail

Ability to manage multiple projects simultaneously

Preferred Skills:

Experience with PLM systems

Familiarity with medical device regulations and labeling requirements

Responsibilities:

Coordinate product labeling activities, including gathering inputs, generating and releasing labeling development plans, and redlining labeling

Collaborate with the design team to ensure labeling changes are implemented accurately

Route updated labels through the PLM system

Attend project meetings regularly and ensure accountability for project deliverables

Track and manage project deliverables across multiple projects concurrently

Support MDR project managers by ensuring labeling updates align with MDR requirements and build dates

Work with designers to provide redlines for updated labels and assist reviewers in addressing questions about MDR labeling requirements

Pay: 45-50

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $45.00 to $50.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance