Regulatory and Compliance Coordinator

Location: Phoenix, AZ

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Job Posted
Apr 10, 2024
Company: TILT Holdings

Company & Role Overview

Summary

Description

About Us

Responsibilities:

  • Understanding customer needs and requirements to develop effective quality control processes
  • Supporting Representative for MDR 2017/745 requirements and responsibilities, including:
    • Ensuring implementation and maintenance of key standards and guidelines.
    • Promoting awareness of regulations and expectations across the organization through strong communication and messaging.
  • Drafts and maintains programs, policies, and procedures to evaluate the quality and performance of Jupiter products and customer processes.
  • Create, implement, update technical documentation for MDR 2017/745 devices.
  • Ensure all medical device technical documentation and any declarations of conformity are drawn up and kept up-to-date.
  • Review and verify any declarations of conformity and technical documentation pertaining to applicable medical devices prior to release.
  • Ensure the organization complies with all post-market surveillance obligations and any applicable reporting obligations are done pertaining to MDR 2017/745 Article 10.
  • Plan and execute projects and team activities to facilitate changes that statistically impact business results, especially as it relates to meeting and exceeding customer expectations.
  • Implement and maintain internal corrective and preventative actions.
  • Assist manufacturers with developing and implementing corrective and preventive action plans to improve overall ISO compliance and quality results.
  • Work directly with the manufacturer to improve product and manufacturing process quality.
  • This role may assume and/or support 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

WHY WORK FOR JUPITER RESEARCH?

  • Medical, Dental & Vision Insurance
  • Flexible Spending (FSA) and Health Savings Accounts (HSA)
  • Prescription Drug Coverage
  • Paid Time-Off (PTO)
  • 11 Paid Holidays
  • Basic and Supplemental Life Insurance
  • Short and Long-Term Disability
  • Leaves of Absences
  • Paid Time-Off to Volunteer in the Community
  • 401(k)
  • Standing Desks & a Stocked Kitchen

Key Competencies Non-Leader:

  • 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.
  • 4+ years of experience in EU MDR 2017/745
  • 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.

TILT is an Equal Opportunity Employer Committed to DEI.

Company BenefitsBenefits for this job may vary.

Career Advancement, Company Discounts, Dental, Medical, & Vision Benefits, Free Snacks / Drinks, Gender Neutral Facilities, Inclusive Environment, Life Insurance, Lunch & Learns, Paid Time Off, Relaxed / Casual Dress Code, Short-Term & Long-Term Disability, Work From Home / Remote

Working Environment

(No Information)

About TILT Holdings

TILT is a combination of leading cannabis companies that deliver products and services to businesses operating in the cannabis industry. Taking care of our people and doing what’s right for the business are complimentary imperatives at TILT Holdings Inc.