Post Market Surveillance Analyst

THE COMPANY:

Juul Labs's mission is to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products. We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.

We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career is compelling, read on for more details.

ROLE AND RESPONSIBILITIES:

As a Post-Market Surveillance Analyst, you'll be an essential part of our Quality Team, supporting the operational integrity of our Post-Market Surveillance system within the Quality Management System. You'll meticulously manage the quality of complaint records, ensuring their completeness and consistency prior to closure. The role demands a deep understanding and precise application of diverse regulatory requirements, including those from FDA Quality System Regulations, Global Tobacco Regulations, and ISO Standards.

• Monitor and accurately assess the quality of the complaint record, ensuring the record is compliant with all processes, regulations and standards.
• Responsible for daily workflow reports to support timely processing and closure of complaints.
• Communicate and manage the correction of non-conforming complaint files to maintain comprehensive, accurate and compliant records prior to closure.
• Monitor complaint record throughput from intake to closure to ensure compliance with regulatory reporting timelines. The timely submission of mandatory reports is non-negotiable.
• Serves as a critical nexus for information flow and collaboration across various internal departments. Drive and support corrective actions, process improvements, and other continuous improvement projects while upholding the company's Quality Management Systems (QMS).
• Communicate business-related issues or opportunities to management in a timely manner.
• Stay up to date with evolving local, regional, and global regulations related to post-market surveillance for tobacco products (e.g., U.S. Tobacco Control Act, FDA's guidance on post-market surveillance).
• Act as a Post-Market Surveillance Subject Matter Expert (SME) during regulatory and internal audits.
• Coordinate various projects and provide day-to-day operational support to management. 

PERSONAL AND PROFESSIONAL QUALIFICATIONS: 

• 3-5+ years of quality, manufacturing, or regulatory experience in a medical device or other FDA regulated industry required.
• Critical thinking and investigation skills. May receive technical guidance on complex problems but independently determines and develops approaches and solutions.
• Strong ability to derive data from enterprise systems, data analysis and trending skillsets.
• Strong analytical, project management and presentation skills.
• Demonstrated understanding of FDA 21 CFR Part 820, ISO Standards and Global Tobacco Regulations.
• Well organized and able to take on multiple initiatives in an ambiguous environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Demonstrated ability to understand and follow complex written procedures.
• Knowledge of general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices
• Demonstrated ability to influence and drive change.
• Prior medical device or pharma complaint handling experience.
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred.

EDUCATION:

Bachelor’s degree in a relevant field such as science, engineering, or safety.

JUUL LABS PERKS & BENEFITS:

• A place to grow your career. We’ll help you set big goals - and exceed them
• People. Work with talented, committed and supportive teammates
• Equity and performance bonuses. Every employee is a stakeholder in our success
• Cell phone subsidy, commuter benefits and discounts on JUUL products
• Excellent medical, dental and vision, disability, and life insurance, plus family support, wellness, legal, and employee assistance program benefits
• 401(k) plan with company matching
• Plus biannual discretionary performance bonuses

Juul Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. Juul Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Juul Labs in the US.