Regulatory Affairs Specialist

Summary:

The Regulatory Affairs Analyst performs activities to provide assurance that Change Healthcare Enterprise Imaging products and business processes comply with relevant current medical device regulations in the countries in which the company does business.

Primary responsibilities are to:

+ ensure that the company's Quality System is compliant with the relevant current medical device regulations

+ ensure that the company's products have the required medical device premarket clearances and licenses to be sold in these markets;

+ provide subject matter expertise, interpretations and training on applicable medical device regulations.

Qualifications Required:

a) Education:

Bachelor degree in Computer Science or Computer Engineering or related discipline; or

Diploma in Quality Management, Regulatory Affairs, or Operations Management; or

Other related education by training or by work experience

b) Experience:

Minimum 2 years of quality systems experience in medical device industry or an ISO 13485 / 9001 regulated industry, or equivalent.

Experience in a software development industry preferred.

Working knowledge of medical device regulations.

Background:

Working knowledge of medical device regulations and standards applicable to software medical device products, including:

+ ISO 13485 Medical Device Quality System Requirements,

+ ISO 14971 / EN ISO 14971 Medical Device Risk Management

+ U.S. FDA Quality System Regulation (21 CFR 820)

+ Canadian Medical Devices Regulations (SOR/98-282)

+ European Medical Device Directives / Regulations

Join our team today where we are creating a better coordinated, increasingly collaborative, and more efficient healthcare system!

COVID Vaccination Requirements

We remain committed to doing our part to ensure the health, safety, and well-being of our team members and our communities. As such, we require all employees to disclose COVID-19 vaccination status prior to beginning employment and we may require periodic testing for certain roles. In addition, some roles require full COVID-19 vaccination as an essential job function. Change Healthcare adheres to COVID-19 vaccination regulations as well as all client COVID-19 vaccination requirements and will obtain the necessary information from candidates prior to employment to ensure compliance.

Equal Opportunity/Affirmative Action Statement

Change Healthcare is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, genetic information, national origin, disability, or veteran status. To read more about employment discrimination protections under federal law, read EEO is the Law at and the supplemental information at \_EEO\_Supplement\_Final\_JRF\_QA\_508c.pdf.

If you need a reasonable accommodation to assist with your application for employment, please contact us by sending an email to with "Applicant requesting reasonable accommodation" as the subject. Resumes or CVs submitted to this email box will not be accepted.

Click here \_%20English\_formattedESQA508c.pdf to view our pay transparency nondiscrimination policy.

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Change Healthcare maintains a drug free workplace and conducts pre-employment drug-testing, where applicable, in accordance with federal, state and local laws.

Change Healthcare is an equal opportunity employer. All qualified applicant will reveive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, genetic information, national origin, disability, or veteran status.