Experienced B.Pharm/ MPharm/ required for REgulatory Affairs in a Medical Device Company, Gurgaon, "D4"

Position: Executive –Regulatory Affairs

Responsibilities:

Compiling & preparation of regulatory dossier submissions a in accordance with the applicable rules and regulations.

He/she participates in all activities relating to registration requirements and line extension indications for all three business units of Stryker India.

 Essential work responsibilities include the final product submissions & providing the RA team with regulatory input in order to obtain timely regulatory approvals for the products as part of the new product approvals, renewals.

Knowledge of MOH set up, Drugs and cosmetics Act and Registration Procedures in India are elementary requirements.

1. Preparation, Compilation and evaluation of Dossiers for registration and renewal as per Indian Regulation for, Medical Devices and Clinical Trials.
2. Evaluation, submission and follow-up of applications for registration of new products, query resolution and deficiency closure.
3. On time submission and follow-up of applications for renewal of registered products
4. Liaison with DCGI office.
5.4. Ensure complete traceability and Audit proof work environment - Maintenance of Trackers, Databases and RA repository for Stryker India product portfolio in accordance with applicable SOPs and guidelines. Monthly update of trackers and archival of the critical documents for records & future reference.

Qualifications/Work Experience:

Education : The successful applicant should have medical device regulatory background, good attention to detail, be self motivated and effective in a team environment under a high work load with multiple responsibilities.

Key characteristics and skills are:

 Degree – Masters of Pharmacy/Bachelors of Pharmacy/Bsc/Msc

Experience: 2-5 years of Medical Device Regulatory experience.

Mandatory Skills :

1 Good Knowledge of Drugs and Cosmetics act pertaining to medical devices.

 2 Good Knowledge of compiling and preparing regulatory dossier for submission to the DCGI.

 3. Good knowledge of medical device scenario in India.

4. Good experience to interact with the DCGI officials. Competencies

5. Effective regulatory and team project management skills

6. Proven problem solving skills Capable of working on fast paced project with significant responsibility

7. Prepared to working to register multiple Stryker sites and device.

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