Regulatory Affairs Executive

Job Title: Regulatory Affairs Executive / Sr. Regulatory Affairs Executive

Location: Thane

Job Responsibilities

• To ensure that companys products comply with Medical Device regulations of different regions where they intend to be marketed
• Well versed with Medical Devices Rules followed in India & overseas
• To involve in registrations of Medical Devices in CDSCO and other international regulatory agencies
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing, etc.) for inputs in dossier preparation.
• Dossier preparations such as Device master file for CDSCO, Technical files preparation for Europe submissions. Preparation of post market surveillance reports, Incident reports to regulatory agencies.
• Additional knowledge of ANVISA, TGA, US FDA, SFDA REACH, MEDSAP wll be an added advantage.
• Should be well versed with online application processes of CDSCO and NSWS for obtaining Manufacturing license, Test license, Import license, Free Sale certification, Non-conviction certificate, Post approval process, License renewal etc.
• Capacity to manage data for accurate presentation of documents to authorities as and when required.
• Participate in CDSCO and other regulatory audits and FDA inspections while abiding to the rules and regulations set by government
• Respond to queries from regulatory authorities.
• Train personnel on regulatory requirements.

Skills Set:

• Extensive knowledge of applicable government regulations for medical devices/invitro diagnostic devices.
• Ability to inform and educate managers and department heads on regulations and policies that require compliance.
• Excellent written and verbal communication skills.
• Excellent analytical and problem-solving skills.
• Excellent strategic planning skills.
• Proficient with applicable database and compliance software.
• Proficient with Microsoft Office or similar software.

Qualification

• Ph.D. with 5-6 yrs. or MSc. with 9-10 yrs. exp.  in Microbiology / Biotechnology + Diploma or equivalent in regulatory or related field.