Analysis Skills, Cardiovascular, Change Control, Communication Skills, Consulting, Corporate Compliance, Detail Oriented, Document Control, Document Management, Documentation, Documentation Review, Implants, Medical Equipment, Medical Products, Organizational Skills, Product Naming, Product Support, Product/Service Launch, Record Keeping, Technical Writing, Work From Home, Writing Skills
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a Compliance Analyst.
Position Type:This role is fully remote, but candidates must be able to align with US Central Time working hours, ideally 8:00 AM to 5:00 PM CT.
Required:- Bachelor’s degree in engineering or related technical field (or equivalent technical certification of ≥350 hours).
- Experience in medical device labeling, packaging documentation, quality documentation, regulatory documentation, or document control.
- Strong understanding of controlled document environments and regulated medical device workflows.
- Experience reviewing and updating IFUs, packaging labels, product files, or related labeling documentation.
- Excellent attention to detail and ability to work through large volumes of repetitive documentation accurately.
- Ability to follow an approved naming convention and apply it consistently across documentation.
- Strong organizational skills and ability to track multiple documents, products, and updates simultaneously.
- Ability to work remotely while aligning with U.S. Central Time business hours.
- Strong written communication skills and ability to document findings clearly.
Preferred:- Experience supporting EU MDR-related remediation, technical documentation updates, or legacy product remediation.
- Prior experience with SmartSolve and/or IQVIA.
- Experience with labeling change control, packaging artwork updates, or document management systems.
- Background in cardiovascular, implantable, or complex medical devices is a plus.
- Experience supporting product launch readiness or post-approval remediation activities.
Responsibilities:- AReview labeling-related documentation for approximately 22 legacy medical device products, including packaging labels, IFUs, and related product files.
- Perform a detailed gap assessment to identify inconsistencies in product naming across controlled documentation.
- Document required labeling and packaging updates based on the approved naming convention provided by the client.
- Support execution of approved updates to labeling, packaging documentation, and related controlled files.
- Work within established document control and change control processes.
- Track progress across a high volume of documents and ensure updates are completed accurately and consistently.
- Collaborate with client stakeholders to clarify documentation requirements, priorities, and review expectations.
- Maintain organized records of reviewed documents, identified gaps, required actions, and completed updates.
- Support readiness for market launch by helping ensure naming consistency across impacted labeling documentation.
Get in Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Shivam at (862) 390-7879 to learn more.#HbM6349
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