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Regulatory Affairs & Compliance Role - Healthcare Service Provider

5.00 to 15.00 Years   Gurugram   16 Mar, 2023
Michael Page
Job LocationGurugram
EducationNot Mentioned
SalaryNot Disclosed
IndustryRecruitment Services
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Industry - Healthcare / Medical / HospitalJob Type - Permanent Description - Regulatory compliance specialist shall be responsible for developing the regulatory compliance strategy , processes, formats , checklists and oversee the execution. The role holder shall also act as a liaison between the organization and various regulatory bodiesClient Details :Our client is one of Indias leading Healthcare service provider with a stellar reputation.Description:- Develop the regulatory compliance strategy / framework / compliance checklists for the various business entities / services of the company- Read and interpret all the relevant acts and rules and prepare the procedures, forms, formats for obtaining regulatory clearances, licenses and permissions- Review all new diagnostics tests from regulatory compliance perspective and develop the appropriate forms , procedures , workflows , guidelines for sample collection, testing, results reporting and post results procedures- Keep track of all the changes in the various applicable laws, acts , rules and modify the existing processes, forms , procedures in alignment with the changes in the laws- Work with Field / Geography teams for obtaining all the necessary regulatory permissions- Develop relationships with central / regional / local regulatory authorities , officials and act as a liaison representing the company for matters pertaining to regulatory affairs- Represent the company in various regulatory forums and act as a SPOC for providing inputs to regulatory authorities for new policy formulations , amendments etc.- Perform periodic planned / surprise audits of various units ( including collection and testing units ) and ascertain adherence to regulatory compliances- Train and develop members of the organization in various regulatory laws, acts, rules, frameworks and strengthen the awareness at field level- Creation / review of the medical content intended for marketing / information dissemination within and outside the organizationProfile :Education - MBBS / MDExperience - 5 years or more experience in managing regulatory complaince for a healthcare setupType of Exposure - Hands on exposure in defining and implementing regulatory frameworks for medical domain - preferably in healthcare diagnosticsAreas of expertise - Thorough knowledge of acts like PCPNDT, AERB, Bio Medical waste management , Solid organ transplant, HIV , clinical establishments act etcIndustry Healtcare - preferably Diagnostics Laboratories, Radiology setup , Hospitals any other Important Skill / requirement,Preference will be given to candidates who have a law degree / certificationThis job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.,

Keyskills :
customer servicebpodeliveryedihuman resourceswaste managementcorporate liaisonregulatory compliancewasteformsorganteststestingbusinessstrategyclinicalmarketingreporting

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