Regulatory Reporting Specialist (Hybrid)

Work Flexibility : Hybrid or Onsite

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

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 contractors legal duty to furnish information.

Required Experience :

IC

Key Skills

Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support

Employment Type : Full-Time

Experience : years

Vacancy : 1