Job description

The Regulatory Labeling Specialist will contribute to MDR and UKCA compliance/remediation initiatives. Initiatives includes strategic labeling advice, writing, and review for major regions. The Regulatory Labeling Specialist will work with cross-functional teams to ensure global regulatory plans are aligned with client strategies and SOPs. This role will require consistent communication with our Regulatory Affairs project teams and/or department stakeholders.

Specific Initiatives include:

• Support initial Gap Analysis including reviewing IFU’s according to an IFU checklist. The review process identifies possible gaps in requirements and source evidence

• Revise the IFU for MDR compliance including reformatting and extensive content writing/revisions. Gathering of source evidence specifically for the IFU safety sections and Directions for Use sections in compliance with MDR

• Support development of compliance deliverables for cross-functional input, hold regular review meetings to ensure comments are addressed, secure approval of final draft, and hand off labeling for CO implementation

• Final quality check of documents for spelling, grammar and formatting

• Editing, formatting and QC performed within systems/software, namely: Adobe InDesign, TVT, Acrolinx, Agile

Job Type: Full-time

Pay: $55.00 - $60.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• FDA regulations: 5 years (Preferred)
• EUMDR: 5 years (Preferred)
• Medical Device: 5 years (Preferred)
• Adobe InDesign: 5 years (Preferred)
• IFU: 5 years (Preferred)

Work Location: Remote

www.colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, www.colinoncars.com is the ideal place to find your next job.