Regulatory Affairs & Compliance Role - Healthcare Service Provider - MBBS/MD

Industry - Healthcare / Medical / Hospital

Job 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 bodies

Client Details :

Our client is one of India's 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 organization

Profile :

Education - MBBS / MD

Experience - 5 years or more experience in managing regulatory complaince for a healthcare setup

Type of Exposure - Hands on exposure in defining and implementing regulatory frameworks for medical domain - preferably in healthcare diagnostics

Areas of expertise - Thorough knowledge of acts like PCPNDT, AERB, Bio Medical waste management , Solid organ transplant, HIV , clinical establishments act etc

Industry Healtcare - preferably Diagnostics Laboratories, Radiology setup , Hospitals any other Important Skill / requirement,Preference will be given to candidates who have a law degree / certification

Job Offer :

An opportunity to work in a critical role for one of India's largest Healthcare Service Provider.

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Utkarsh Gupta on +91 124 452 5469.

Contact - Utkarsh Gupta - +91 124 452 5469

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