Regulatory Reporting Specialist (Hybrid)

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 organizations compliance with FDA European and global requirements governing adverse event 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 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

• Bachelors degree (B.S. or B.A.) preferably in Science Engineering or related field

• 02 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