Analyst, Product Surveillance II

Analyst, Product Surveillance II

Our client, a leader in the Medical Device and Pharmaceutical industry, is seeking an Analyst, Product Surveillance II to join their team. As an Analyst, Product Surveillance II, you will be part of the Post Market Surveillance department supporting regulatory compliance and product safety initiatives. The ideal candidate will demonstrate attention to detail, analytical thinking, and a proactive approach, which will align successfully in the organization.

What's the Job?

• Determine classification, review, and disposition of adverse events and complaints for on-market products
• Complete FDA Medical Device Reports (MDR) and other regulatory submissions for global authorities including Europe and Hong Kong
• Manage product experiences by assessing seriousness, reportability, and potential causality of adverse events
• Collaborate with regulatory teams to ensure compliance with 21 CFR Part 820, Part 803, and other relevant regulations
• Support multiple functions within the post-market surveillance department to ensure product safety and regulatory adherence

What's Needed?

• 3-5 years of related experience in post-market surveillance within the Medical Device or Pharmaceutical industry
• Experience with MDR and OUS regulatory reporting (Europe, Hong Kong) highly preferred
• Four-year degree in healthcare, science, or a related field; or a 2-year degree with relevant experience
• Proficiency with MS Office Suite, especially MS Word and Excel
• Ability to work independently, multitask effectively, and pay close attention to detail

What's in it for me?

• On-site work environment with flexible working hours, including potential for one day remote after training
• Opportunity to work in a dynamic, collaborative team supporting critical product safety functions
• Potential to extend the contract based on performance and business needs
• Engage in meaningful work that impacts patient safety and regulatory compliance
• Work in Minnetonka, MN, with a supportive and inclusive company culture

Upon completion of waiting period, consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.