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
Travel Percentage: 10%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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.