Company: Class III Medical Device
Duration: 3 Month Contract, with possibility for extension/going perm.
Location: Remote. Preference for candidates in CST or EST time zones. Being based in MN or NJ is a plus.
Start Date: ASAP
Type: No W2 or third party companies.
Pay: Commensurate with experience
Our client is a Class III medical device company that is on the verge of securing their first FDA approval, entering the US market and scaling up. Additionally, continuing their EU commercial expansion. We're looking for a Senior Global Labeling Specialist to support these efforts.
Responsibilities:
- Leading labeling projects from conception through to approval and implementation.
- Creating, reviewing, and updating labels, instructions for use (IFUs), package inserts, and other labeling materials.
- Verifying that all company labeling meets regulatory requirements and guidelines.
- Working closely with regulatory, quality, marketing, and product development teams to ensure accurate and compliant labeling.
- Assessing potential risks related to labeling changes and implementing appropriate controls.
- Providing training and support to other departments regarding labeling requirements and procedures.
- Maintaining accurate records of labeling approvals and changes.
Qualifications Skills and Competencies:
- A minimum of 6 years of experience in product labeling within the medical device industry, with comprehensive end-to-end ownership.
- Extensive knowledge of FDA labeling requirements (21 CFR Part 801) and international labeling standards.
- At least Class II medical device experience is required; experience with Class III devices/implantables is great to have.
- Ability to work effectively in a team environment and with various stakeholders, including R&D, marketing, regulatory affairs, and quality assurance.
- Familiarity with labeling software and tools such as Adobe Illustrator, Labeling Management Systems (LMS), and Microsoft Office Suite.
- Proven ability to create clear, accurate, and compliant labeling content, ensuring adherence to regulatory standards and error-free output.
- Strong project management skills, effectively handling multiple projects and deadlines.
- Expertise in analyzing data and regulatory documents, with excellent verbal and written communication skills for cross-functional team interactions.
- Proficient in troubleshooting and resolving labeling issues promptly.
Certifications (Optional but Preferred):
- Regulatory Affairs Certification (RAC)
- Certified Labeling Specialist
Job Type: Contract
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Application Question(s):
- Describe your relevant product labeling experience within the medical device industry. Specifically include your Class III exp (if applicable) and supporting FDA labeling requirements (21 CFR Part 801) and international labeling standards.
Work Location: Remote