Regulatory & Compliance Coordinator

Position: Regulatory & Compliance Coordinator
Department: Engineering
FLSA Status: Exempt
HQ Location: Scottsdale, AZ
Remote Work: Hybrid
Report to: ​Quality Assurance Manager or Engineering Director
Salary/Pay:  $70,000 – $80,00 annualized
Direct Reports: N/A

Job Description

The role of Regulatory and Compliance Coordinator is responsible for supporting regulatory and compliance activities for Jupiter Research medical devices in accordance with EU MDR (2017/745) and applicable quality system requirements, including ISO 13485:2016. This role focuses on regulatory documentation, post-market compliance, change impact assessments, and coordination with external partners such as distributors and the Authorized Representative, and assists with internal and external audits. The position ensures regulatory continuity across the product lifecycle and supports compliance activities related to Technical Documentation, post-market surveillance and regulatory change management.

Responsibilities/daily tasks:

• Support the development, maintenance, and improvement of the Jupiter Quality Management System as it relates to ISO 13485:2016 and Regulation MDR 2017/745

  •  Understanding regulatory, customer and stakeholder requirements to support compliance activities and ensure regulatory expectations are appropriately addressed.

  • Support ongoing compliance with EU MDR (2017/745) and, ISO standards and applicable international regulations., including:

    • Ensuring implementation and ongoing maintenance of applicable regulatory standards and guidelines.

    • Promoting awareness of regulatory regulations and compliance expectations across the organization through strong communication and messaging.

  • Draft, review and maintain SOPs, work instructions, and templates related to regulatory and compliance activities.

  • Support post-market surveillance (PMS) activities, including post-market clinical follow-up (PMCF) and complaint monitoring in line with EU MDR Articles 83–86.

  • Support regulatory reporting of adverse events, field safety corrective actions (FSCAs), and vigilance reporting in accordance with EU MDR Articles 87–92.

  • Support regulatory aspects of complaint handling, including documentation review, trend analysis, and reporting in accordance with regulatory requirements.

  • Review product, labeling, and process documentation to ensure regulatory alignment and completeness.

  • Draft, review, and maintain Technical Documentation and regulatory records, ensuring all design, manufacturing, labeling, and Instructions for Use (IFU) changes are evaluated and documented in compliance with EU MDR requirements.

  • Assist with internal and external audits by preparing documentation and responding to information requests.

  • Ensure that all regulatory documentation, including Technical Files, Device Master Records, Declarations of Conformity, and supporting evidence such as clinical evaluation reports, risk management files, verification/validation records, labeling/IFU documents, and post-market surveillance data, is complete, accurate, and maintained up-to-date.

  • Support documentation and regulatory oversight of corrective and preventive actions (CAPA)

  • Coordinate with distributors, suppliers, and the Authorized Representative to support regulatory compliance activities.

  • Facilitate regulatory change assessments and ensure required documentation and communication are completed.

  • Collaborate cross-functionally with Quality, Engineering, and Operations teams to ensure regulatory requirements are understood and addressed.

  • Regulatory and Compliance Coordinator may assume the responsibility of ‘Person Responsible for Regulatory Compliance’ (PRRC) per MDR Article 15 / Management Representative.

    • The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.

    • The technical documentation and the EU declaration of conformity are drawn up and kept up to date

    • The post-market surveillance obligations are complied with in accordance with Article 10(10)

    • The reporting obligations referred to in Articles 87 to 91 are fulfilled.

    • In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Qualifications: Experience, Education

• Education: Diploma, certificate, or other evidence or formal qualification awarded on a completed university degree.
  • A course recognized as equivalent by the Member state concerned in:
    • Law, Medicine, Pharmacy, Engineering, or other relevant scientific disciplines.
  • At least one year of professional experience in Regulatory affairs or in QMS relating to Medical Devices.
• Experience: 4 years of professional experience in regulatory affairs or in Quality Management systems related to Medical Devices.
• Technical Skills: Proficiency in Warehouse Management Systems (WMS), Inventory Management Software, Enterprise Resource Planning (ERP) systems and Excel.
• 5+ years of experience with Quality Assurance programs.
• 4+ years of manufacturing environment experience
• 4+ years of experience in an ISO-9001 / ISO 13485:2016 QMS.
• Experience with method development and optimization.
• Experience working in cross-disciplinary teams.

Working Conditions/Physical Demands:

• This position works in a fast-paced laboratory/office environment.  
• Must be willing to travel and obtain a Chinese visa (international a possibility).  
• Must be able to sit and stand for up to eight (8) hours a day.  
• This position requires light work with 50 pounds maximum weight to lift and carry.

Compensation & Benefits:

• Health, dental, and vision insurance
• Paid time off and holidays
• Opportunities for growth in a rapidly expanding industry

The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job.  The above is not intended to be an exhaustive list of all responsibilities and duties required.

TILT is an Equal Opportunity Employer Committed to DEI.  All qualified job applicants receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are committed to fostering diversity and leveraging the value of diversity with equity and inclusion.

For Company information, visit: www.tiltholdings.com