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Job Req ID:  3114

Job Title:  Quality & Regulatory Manager - All Covered

All Covered, IT Services Division of Konica Minolta Business Solutions (KMBS), is the leading national IT services company serving SMB to enterprise markets. Offering a wide variety of career opportunities, All Covered is an excellent choice for motivated IT professionals interested in a stimulating and progressive work environment.


With over 1,000 employees across the U.S. and Canada, All Covered has a highly skilled team of professionals focusing on superior quality service delivery to our customers. We offer hands-on technical training on the most relevant technologies in the industry and career path advancement in all levels of the company.


Please join us in our exciting growth and pursue a rewarding career with All Covered!

Position Objective

The Quality & Regulatory Manager will support a multi-disciplinary team dedicated to create healthcare IT innovation products and services for the US market.

The Quality & Regulatory Manager assumes responsibility and control for creation, adaption and implementation of relevant processes and best practices in Healthcare IT development.

The Quality & Regulatory Manager shall also act as a mentor for the team and management in regards to regulatory standards and requirements in Healthcare IT and acts as the authority on regulatory requirements.

The Quality & Regulatory Manager is also the coordinator & facilitator for regulatory certification process (e.g. HITRUST) where necessary in the project.

For this position is important to be have an expert level understanding of applicable standards and regulations in Healthcare IT (e.g. HIPAA MACRA, data privacy and Protection)  and to have at least working knowledge on the function of standard Healthcare IT systems ( e.g. HIS, EHR, PACS/RIS)

Essential Job Functions

The Quality & Regulatory Manager will initiate processes and implement best practices in a healthcare IT project that is not in the market yet. This entails responsibility for:

  • Compliance of project and product documentation
  • Procedures, best practices and policies
  • Healthcare IT product/service compliance with US regulations (e.g. HIPAA, MACRA, NIST, FDA if applied, GDPR, etc.)In the role, the Quality & Regulatory Manager will be responsible for:
  • Creation and maintenance of a Quality System for this healthcare IT project
  • Definition of project and product requirements (requirements engineering) to be compliant with US healthcare IT regulations
  • Coordinate/require the project team and involved organization to meet quality standards
  • Establish and control documentation processes (e.g. GMP)
  • Compliance of Healthcare IT products/services
  • Communication and mentorship in regards to regulatory compliance
  • Collaboration with various stakeholders in a multi-cultural virtual team.
Competencies (Knowledge, Skills and Abilities)
Experience, Educational Reqts and Certifications

Education

Bachelor or Master degree Level in computer sciences, SW/Systems Engineering or similar areas.

Professional Skills:

  • 5+ years of experience working as Quality/ Regulatory Manager or similar in the Healthcare IT Industry, ideally in the US.
  • Experience in establishing compliant development and documentation guidelines and processes (e.g. GMP in healthcare IT).
  • Proven experience in defining product requirements in an agile development environment.
  • Ability to understand and identify regulatory requirements of new healthcare IT products/services
  • Basic understanding of regulatory and legal implications and interactions of Healthcare IT offerings and BAA liabilityexperience working in large organization
  • Strong Oral and Written communication skills in English
  • Ability to deal with uncertainty and keep structured. You will work in an innovative environment where things can change fast.
  • Solid prioritization and structuration skills
  • Ability to work in virtual teams

Konica Minolta Offers: 

  • Competitive salary
  • Outstanding benefits package (including medical, dental, vision, life insurance)
  • 401(k) plan with matching company contribution
  • Generous holiday and paid time off schedules
  • Tuition Reimbursement Program
  • Ongoing professional development training

Konica Minolta is an equal opportunity and affirmative action employer. We consider all qualified applicants for employment without regard to race, color, religion, creed, national origin, sex, pregnancy, age, sexual orientation, transgender status, gender identity, disability, alienage or citizenship status, marital status or partnership status, genetic information, veteran status or any other characteristic protected under applicable law.


Nearest Major Market: Atlanta