Regulatory Affairs Executive

JOB DESCRIPTION – REGULATORY AFFAIRS EXECUTIVE

 KNOWLEDGE OF REGISTRATIONS OF COMPANY WRT VARIOUS LAWS AND REGULATIONS COMING UP FROM TIME TO TIME WRT BUSINESS IN MEDICAL DEVICES INDUSTRY.

 AERB, PNDT, PCPNDT, CDSC, PWM, EWM, BWM & BIS REGISTRATION AS AND WHEN

REQUIRED WITHIN TIMELINES.

 ISO 13485 AUDIT AND DOCUMENT REQUIREMENTS AND PROCESS KNOWLEDGE.

 HAVE A CLEAR UNDERSTANDING WRT THE REQUIREMENTS OF THE SAME AND ALSO ABILITY

TO GET IT DONE WITHIN REQUIRED TIME FRAME BY CLOSELY WORKING WITH TEAM

INVOLVED BOTH INTERNAL AND EXTERNAL TO THE COMPANY

 KEEP ONLINE WITH THE CHANGES AS HAPPENED FOR ALL STATUTORY REGISTRATIONS NOT LIMITED TO ABOVE AND INFORM MANAGEMENT ON THE SAME AND WORK TOWARDS COMPLIANCE AGAINST THE SAME

 SUPPORT SALES, ACCOUNTS AND ADMIN TEAM WRT THE DOCUMENTATIONS ON THE

REGISTERATIONS AS AND WHEN NEEDED.

 KEEP UPDATED ON THE PCPNDT AND AERB RULES AND COMPLY AS PER THE SAME ON

MONTHLY AND QUARTERLY BASIS AS PER SCHEDULE MENTIONED IN THE RULE

 ANY OTHER RELATED AS ASSIGNED BY THE MANAGEMENT FROM TIME TO TIME.

REQUIREMENT OF CANDIDATE.

 DIPLOMA /BSC/BCOM/ BA/ISO 13485 CERTIFICATION PREFERABLY WITH MANAGEMENT

QUALIFICATION.

 ATLEAST 2 TO 3 YEARS EXPERIENCE IN THE REGISTRATIONS OR REGULATORY OR LEGAL DEPARTMENT WITH PROCESS KNOWLEDGE.

 HAVE ADEQUATE KNOWLEDGE ABOUT ONGOING PROCESSES AND ABILITY TO

UNDERSTAND AND IMPLEMENT ANY NEW REQUIREMENTS AS THEY COME

 WILLINGNESS TO LEARN AND KEEP UPDATE ON ABOVE LAWS AND LEARN NEW LAWS.

 HACE CONTACTS WITH RESPONSIBLE PERSON FOR THE ABOVE DOCUMENTATION.

 WILLING TO WORK AND TRAVEL EXTENSIVELY WITHIN OR OUT OF HO TO GET THE

REQUIRED JOBS DONE.

 HAVE ADEQUATE KNOW HOW OF TENDER RELATED DOCUMENTATION AND ACTIVITIES.

Location: Mumbai , AmberNath.

Job Type: Full-time

Pay: ₹30,000.00 - ₹35,000.00 per month

Benefits:

• Health insurance
• Paid sick time
• Paid time off
• Provident Fund

Experience:

• total work: 1 year (Preferred)

Work Location: In person