Regulatory Compliance Specialist (REMOTE) - Arizona, Tempe 1830 W Drake Dr

Work Flexibility: Remote

Stryker is hiring a Regulatory Compliance Specialist (Remote) to help integrate the Stryker Sustainability Solutions post-market surveillance department within the Stryker Endoscopy division.

Who we want:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

What you will do:

• Review reports of customer complaints and assess them for regulatory reporting.

• Submit initial and follow-up reports to device related agencies as appropriate.

• Analyze complaint data.

• Work with customers and sales forces to resolve complaint issues.

• Interact with device related Agencies on vigilance reports and incidents.

• Prepare written customer communications by translating technical medical device complaint investigation reports into customer letters.

• Process Additional Information (AI) request letters from the FDA.

• Recommend corrective and/or preventive actions to address non-conformities and deviations.

• Work and train other departments on their complaint handling responsibilities.

• May assist in determining when product field actions are required in accordance with procedures.

• May assist in completing product field action documentation.

• Assist in developing solutions and processes to manage complaints and to prevent further complaints.

• Maintain current on CHS TrackWise system and provide training as needed.

• Participate in all post-market surveillance activities as needed and facilitate Post Market Surveillance Meetings

• May review and approve non-conformances and planned deviations.

• May aid in developing and executing process and product protocols and reports.

• May provide backup phone support to the complaint hotline.

• May work with pre-market Regulatory personnel in developing post-market product requirements.

• Support management of high-level projects and initiatives, with responsibilities that include defining, managing and executing project charters and partnering with cross-functional groups to establish roles, responsibilities, and deliverables.

• Capable of clearly identifying, analyzing, and understanding potential risks and problems and work with management to and assure the appropriate actions are taken.

• Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and support process improvement initiatives to maximize efficiencies.

What you need:

Required

• Bachelor's degree required, engineering or science degree preferred

Preferred

• Experience working in medical device, biologics and/or pharmaceutical field preferred

• Proficient in Microsoft Office, Excel and Powerpoint

• Knowledge of applicable international regulations and standards (CFR, EU MDR, QSR, ISO 13485, CMDCAS, etc.)

• Ability to interface with both technical and non-technical personnel at all organizational levels

• Technical writing experience preferred

• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines

• Regulatory Affairs Certification and or ASQ Certification preferred

• Prior experience working in a virtual/remote environment with demonstrated capabilities to work with minimal supervision.

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.