Regulatory Affairs - Senior Coordinator

Regulatory Affairs Sr. Coordinator

Location: Ahmedabad, Gujarat
Experience: 2 – 4 years
Shift Timing: 9:00 AM – 6:00 PM (Monday to Friday)

About BIOTEK

BIOTEK is a global medical device company dedicated to developing innovative products in the advanced Orthopaedic sector – Sports Medicine. With a strong presence across all six continents, our products continue to experience exceptional global growth and demand.

Role Overview

As a Regulatory Affairs Sr. Coordinator, you will play a pivotal role in managing regulatory submissions for orthopaedic implants and instruments across regulated, semi-regulated, and domestic markets. You will serve as a key contact for addressing regulatory-related product queries from internal teams and external stakeholders.

Key Responsibilities

• Understand and interpret country-specific requirements for new product registrations, renewals, labeling, and tender submissions; create compliant regulatory dossiers.
• Identify and address gaps in product, process, and labeling compliance; support non-conformity assessments and CAPA implementation.
• Liaise with distributors and regulatory consultants for country registrations, providing documentation and official letters in coordination with relevant departments.
• Conduct gap analysis of labeling and packaging documents in line with EU MDR and 21 CFR 820, and drive corrective action plans.
• Provide technical regulatory support, interpreting relevant regulations for products, processes, and documentation.
• Ensure ongoing compliance of certified and new products throughout their lifecycle.
• Maintain and update regulatory registers, product lists, Declarations of Conformity, and standards lists.
• Manage and implement change control processes for regulatory documentation.
• Coordinate with cross-functional teams for preparation and submission of regulatory documents.
• Perform additional tasks as directed by senior management.

Essential Skills & Knowledge

• Strong knowledge and hands-on experience in dossier preparation per:
• ISO 13485, ISO 14971, ISO 20417, ISO 11607, ISO 15223
• EU MDR 2017, FDA 21 CFR, QMS/QSR, and CDSCO guidelines (specific to orthopaedic medical devices).
• Familiarity with GSPR, ICH guidelines, and international QSR standards.
• Knowledge of regulatory submission requirements for multiple regions — APAC, CEMA, MEA, LATAM — is an advantage.
• Proficiency in Microsoft Office and SharePoint.
• Excellent written and verbal communication skills in English.

Educational Qualification

• Bachelor’s or Master’s degree in Pharmacy OR
• Master’s in Medical Device Regulatory Affairs with a minimum of 2 years’ experience in the medical device industry.

Job Types: Full-time, Permanent

Pay: ₹600,000.00 - ₹750,000.00 per year

Benefits:

• Commuter assistance
• Paid time off
• Provident Fund

Work Location: In person