Regulatory and Compliance Coordinator

Position: Regulatory and Compliance Coordinator
Department: Engineering
FLSA Status: Exempt
HQ Location: Scottsdale
Remote Work: Hybrid / Remote
Report to: Senior Director of Engineering
Salary/Pay:  $65,000 – $80,000
Direct Reports: Yes

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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.

Key Competencies

• Functional Acumen – Consistently shows comprehensive knowledge, skills, and abilities in the functional area(s) for which they are responsible, and understand the fit with overall business goals
• Emotional Intelligence – Consistently executes the four (4) principles of EQ (i.e., self-awareness, social awareness, self-management, relationship management)
• Intellectual Agility:  Consistently evaluates challenges and opportunities from a variety of angles, taking in multiple inputs, and arrives at reasonable business decisions.
• Collaborate – Consistently maintains effective teaming relationships with internal parties, and as applicable, external parties
• Dependable – Can be consistently trusted to execute their job responsibilities on-time and within the scope and meets or exceeds targeted business results.
• Upholds Company Values – Consistently role models and supports execution of the Company’s core values.

Qualifications:

• Diploma, certificate, or other evidence or formal qualification awarded on a completed university degree or a course recognized as equivalent by the Member state concerned in:
  
  • Law, medicine, pharmacy, engineering, or other relevant scientific disciplines and at least one year of professional experience in Regulatory affairs or in QMS relating to Medical Devices.
• Or four years of professional experience in regulatory affairs or in Quality Management systems related to Medical Devices.
• 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:

• Competitive base salary
• 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.

Jupiter Holdings 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.