Regulatory Affairs Specialist II - Supervisory Review

Employer
DNV
Location
Phoenix, Arizona
Posted
Dec 01, 2023
Closes
Dec 10, 2023
Ref
2685666223
Position Type
Specialist
Hours
Full Time
Organization Type
Corporate, Other Corporate
Local Unit & Position Description

DNV Healthcare is a CMS-approved National Accreditation Organization. We are the only accreditor that integrates the ISO 9001 Quality Management System with the Medicare Conditions of Participation. We aim to change the culture of accreditation and help our customers create a sustainable culture of quality and safety.

The US Regulatory Affairs Dept provides pre-survey and post survey support to integrated accreditation/ISO 9001 survey teams and client hospitals under rules established by CMS and ISO CB.

The primary function of the Regulatory Affairs Specialist II - Supervisory Review is to provide knowledgeable, authoritative support to the accreditation and certification function and to build confidence among clients, surveyors and certification bodies of the integrated support functions in DNV Healthcare.

This position will ideally be located in our US offices, to include Cincinnati,San Diego, Oakland, Portland, Seattle, Medford, Austin, Houston, Columbus, Detroit, Austin, Dallas with flexible work arrangements

What You'll Do:
  • Ensure that the work is performed in accordance with the quality requirements of the activity, the instructions of the Manager of Regulatory Affairs or designee, and the procedures governing the activity
  • Responsible for ongoing compliance with DNV ICPs related to Accreditation/Certification
  • Plan and execute accreditation supervisory review work, both pre-survey and post-survey, within agreed timescales, as required by CMS and other certification bodies
  • Review survey schedule in advance to ensure appropriate information and materials are available and ready for supervisory review
  • Preliminary-to-Final Report Review - all incoming survey reports, all activity types
  • Ensuring each final report is complete and accurate, to satisfy customer need and CB requirements.
  • Tracking and auditing of results and data for review associated with all survey activities
  • Maintain accurate records of all accreditation review activity, including logs, surveyor submissions, survey reports, etc using established, secure DNV systems
  • Ensure the independent nature of the accreditation requirements are not compromised at any time
  • As assigned, assist with tasks and responsibilities of the roles of Regulatory Affairs Specialist or Standards Application and Interpretation (SAI) Specialist
  • Cross trains with all members of the Regulatory Affairs Team for ad hoc coverage of department including but not limited to responsibility for pre-survey and post survey activities, on-call assignment, dropbox coverage, data collection and analysis
  • Other duties assigned by appropriate management

Position Qualifications

What is Required:
  • Bachelor's Degree in related field.
  • 3+ years of demonstrated experience in healthcare provider settings,
  • Must have, or develop within three months, appropriate skills in the use and management of DNV information systems, specifically Oracle NGPS and DNV Scheduler, Outlook
  • Proficient in Microsoft Office, including Word, Excel, and SharePoint functionalities, and other related software necessary to manage the required Accreditation scope of work.
  • Physical abilities necessary to perform regular functions of the job (standing, lifting, climbing, other)
  • Travel (approx 5%) for annual training - ability to fly commercial, drive and rent a car, travel independently, carry luggage
  • We conduct a pre-employment background check and drug screen


What Is Preferred:
  • Healthcare provider Clinical or Quality leadership experience preferred
  • Experience in an area related to Health care such as Education, Human Resources, Quality or other Healthcare related fields optional.
  • Qualified as DNV Healthcare Surveyor
  • Clinician or dual Generalist/Clinician
  • DNV Healthcare Survey Team Leader, Clinician or Generalist
  • ISO 9001 lead auditor


Immigration-related employment benefits, for example visa sponsorship, are not available for this position

What We Offer
  • Generous Paid Time Off (Vacation, Company Holidays, Parental Leave, Sick, and Disability)
  • Multiple Medical, Dental, and Vision Benefit Plans to choose from
  • Spending Accounts - FSA, Dependent Care, Commuter Benefits, Company-Seeded HSA
  • 401(K) with company match
  • Company provided life insurance, short-term, and long-term disability benefits
  • Education reimbursement program
  • Employer-Paid, therapist-led, virtual care services through Talkspace
  • Flexible work schedule with hybrid/remote opportunities


Benefits may vary based on position, tenure, location, and employee election

How We Do It

We Care, We Dare, We Share

DNV is a proud equal opportunity employer committed to building an inclusive and diverse workforce. All employment is decided on the basis of qualifications, merit or business need, without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

DNV is committed to ensuring equal employment opportunity, including providing reasonable accommodations to individuals with a disability. US applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may contact the North America Recruitment department ( ). Information received relating to accommodations will be addressed confidentially.

DNV is proud to announce being named one of Houston's best places to work in the 2022 Houston Business Journal - Best Places to Work competition.

For more information about your rights under the law, see:

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Diversity at DNV

Meet our Employees

About DNV

Careers in DNV

Company & Business Area Description

DNV Supply Chain & Product Assurance

DNV is an independent assurance and risk management provider, operating in more than 100 countries. Through assessment and digital assurance solutions, DNV helps companies build trust and transparency around products, assets, supply chains and ecosystems.

Whether certifying products, verifying claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results.

Combining sustainability, supply chain and digital expertise, DNV works to create new assurance models enabling interaction and transaction transparency across value chains. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

Driven by its purpose, to safeguard life, property, and the environment, DNV helps tackle the challenges and global transformations facing its customers and the world today and is a trusted voice for many of the world's most successful and forward-thinking companies.

Equal Opportunity Statement

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!