• Regulatory Reporting Specialist (Hybrid)

    Stryker (Fort Lauderdale, FL)


    Stryker is currently seeking a **Regulatory Reporting Specialist** to join our Joint Replacement Division to be based hybrid in Weston, FL.

     

    What you will do

     

    As the **Regulatory Reporting Specialist** , you will be responsible for ensuring the organization’s compliance with FDA, European, and global requirements governing adverse event reporting. In this role, you will gain the clinical and regulatory experience required to accurately assess the reportability status of incoming complaints associated with hip, knee, limb salvage, and robotic devices utilizing risk documentation. In addition to managing adverse event reporting activities, you will have the opportunity to collaborate with several post-market teams and support continuous improvement and efficiency projects.

     

    + Review reports of customer complaints and assess them for MDR / MIR reportability to FDA / Competent Authorities

    + Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines

    + Partner with Quality Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision

    + Support interactions with Regulatory Agencies as required

    + May aid in updating current procedures/processes or assist in creating new procedures/processes

    + Review and analyze data for trending purposes

    + Track metrics on process timeliness and effectiveness

    + Participate in Post-Market Compliance initiatives

     

    What you need

    Required

    + Bachelor’s degree (B.S. or B.A.), preferably in Science, Engineering or related field

    + 0–2 years of experience as a regulatory or quality professional in a regulated manufacturing environment

    + Ability to manage multiple tasks and meet deadlines

    Preferred

    + Experience with post-market MDR/MIR reporting

    + Applied knowledge of US and International Medical Device Regulations and Standards including but not limited to: FDA: CFR 21 Part 803 (MDR), and CFR 21 Part 820 (QSR), MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System), ISO 13485 (International Organization for Standardization)

    + Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development and Marketing and Quality.

    + Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality

     

    Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

     

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.