Sr. Labeling Project Specialist Contractor- Irvine, MN

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

The Senior Labeling Project Specialist (LPS) plans, manages, trains, and directs the creation and revision of product literature and labeling through their own work and through others. The LPS works closely with project teams to ensure labeling content is developed per, and compliant to, all applicable procedures, regulations, and standards. The LPS ensures labeling deliverables are completed per the schedule and maintains a high standard of quality.

The LPS will work to streamline processes, cross-train personnel, and continuously improve. The LPS will engage with stakeholders and work collaboratively across functions, regions, and business units. The LPS is the resident expert and primary point of contact for all things related to product literature and labeling. 

12 Month Contract

Responsibilities:

• Managing product labeling projects.
• Developing labeling project strategies and schedules to outline work plans, timelines, roles, and resources. Anticipate potential barriers and develop alternatives and mitigation strategies.
• Facilitating training on labeling procedures and labeling software and systems.
• Leading product labeling project teams to complete activities per policies and practices to produce and release product labeling deliverables.
• Effectively communicating project statuses, challenges, and successes on a regular basis to project and functional management in various meetings.
• Ensuring on-time completion of deliverables.
• Monitoring and working with project management and functional management to address issues that could negatively impact schedule or quality. 
• Coordinating all product labeling deliverables (will vary by project), including labels, IFUs, and carton and pouch artwork, etc. 
• Leading cross functional teams through content development for labeling deliverables by managing the drafts, collecting input and source data, making changes, tracking revisions, and keeping teams on schedule. 
• Fostering and improving content consistency across labeling. 
• Facilitating team reviews of labeling deliverables to ensure content is accurate, complete, fully compliant to relevant regulations and requirements, and meets the needs of the customer. 
• Coordinating desktop publishing and labeling artwork generation. 
• Coordinating implementation/release activities of labeling deliverables, including elabeling. 
• Managing content changes (and mitigating the impact on schedule and consistency) by pushing teams to focus on accuracy and completeness. 
• Leveraging expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors.

Requirements:

• Associate degree or bachelor’s degree
• 7+ years’ work experience in regulated industry
• Medical Device experience 
• 5+ years Labeling experience 
• Direct labeling or technical writing experience desired
• High attention to detail
• Ability to manage several projects concurrently
• Ability to learn new skills and adapt to business needs
• Medical Electrical Equipment / Capital Equipment experience 
• Adobe Suite Creative Suite experience strongly preferred
• MS Office and MS Project experience strongly preferred
• Project Management experience
• Prisym, Bartender or other label design software and database experience preferred
• Scrum and agile methodology experience preferred
• Ability to travel up to 15% including some international travel

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

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