• Product Surveillance Analyst II

    Actalent (Minneapolis, MN)


    Job Title: Product Surveillance AnalystJob Description

     

    The Product Surveillance Analyst will perform electronic record management functions and regulatory reporting within complaint handling, focusing on complaint investigation management. This includes activities related to receiving and investigating reports of worldwide product events, entering information into the database, and independently determining and filing appropriate medical device reports with various regulatory agencies. The current project requires high volume record intake and individual electronic submission of regulatory reports for similar product events. This role supports the CRM business unit, which includes products such as pacemakers, leads, and implanted cardiac monitors, and serves the EU and Hong Kong markets.

    Responsibilities

    + Perform electronic record management and regulatory reporting within complaint handling.

    + Investigate reports of worldwide product events and enter information into the database.

    + Independently determine and file appropriate medical device reports with regulatory agencies.

    + Manage high volume record intake and electronic submission of regulatory reports.

    + Communicate effectively with employees, customers, and external clients/sales reps.

    + Fill in templated forms for reporting bodies in various countries.

    Essential Skills

    + Bachelor's Degree in a science-related field.

    + 2+ years of experience in post-market surveillance, medical device, or pharmaceutical industry.

    + Strong problem-solving skills.

    + Proficient at navigating computer systems.

    + Experience in investigations, medical device reporting, or product evaluation.

    + Writing experience.

    Additional Skills & Qualifications

    + Previous knowledge of global regulations for medical device reporting.

    + Medical terminology knowledge.

    + Experience in OUS regulatory reporting or MDR.

    Work Environment

    This is a desk-based role within a team environment, though much of the work is performed independently. The position requires working 8 hours a day from a computer, involving phone work, team meetings, and product meetings. The team consists of 12 people and collaborates closely with teams in CA and Malaysia that support USA and non-EU/Hong Kong markets. The role requires being in the office 4 days a week in Minnetonka, with Tuesday as a mandatory day due to team meetings. There is potential for remote work, although this is not guaranteed.

    Pay and Benefits

    The pay range for this position is $24.00 - $29.00/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

     

    Workplace Type

     

    This is a hybrid position in Minneapolis,MN.

     

    Application Deadline

     

    This position is anticipated to close on May 15, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.