Senior Regulatory Affairs (RA) Specialist

Healthminds; Bengaluru; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

HealthMinds Consulting Private Limited in Bengaluru seeks a Senior Regulatory Affairs Specialist to lead global regulatory strategies for medical devices and combination products, coordinating with R&D, Quality Assurance, Clinical Affairs, Manufacturing, Supply Chain and Marketing.

You will prepare regulatory submissions, maintain registrations, and support product lifecycle activities to ensure compliance with FDA, EU MDR, and other international requirements across markets.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or related discipline.
• 5+ years of experience in Regulatory Affairs within the medical device or combination product industry.
• Experience preparing regulatory submissions and technical documentation for global markets.
• Working knowledge of FDA regulations, EU MDR requirements, and international medical device regulations.
• Experience with regulatory change assessments, product registrations, and lifecycle management activities.

Responsibilities

• Support the development and implementation of regulatory strategies for medical devices and combination products across global markets.
• Prepare, compile, review, and maintain regulatory submissions including FDA 510(k), PMA, De Novo, EU MDR Technical Documentation, and international registration dossiers.
• Perform regulatory impact assessments for product design changes, manufacturing changes, software updates, supplier changes, process changes, and labeling revisions.
• Support product lifecycle management activities by maintaining regulatory compliance and global market registrations.
• Prepare and maintain Technical Documentation, GSPR checklists, compliance matrices, and regulatory evidence packages.
• Review and update product labeling, Instructions for Use (IFUs), packaging artwork, UDI requirements, and marketing materials to ensure regulatory compliance.
• Support regulatory activities during product development, design reviews, risk management, verification and validation activities, and change control processes.
• Support regulatory strategy and documentation activities for combination products.
• Prepare documentation packages for internal audits, supplier audits, notified body audits, and regulatory inspections.
• Maintain regulatory databases, submission trackers, product registration records, and compliance documentation systems.
• Conduct regulatory research and support assessment of evolving regulatory requirements.

Skills

Regulatory affairs

Regulatory submissions

Technical writing

Cross-functional collaboration

Attention to detail

Education

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or related discipline

Job description

HealthMinds Consulting Private Limited | Full time

Senior Regulatory Affairs (RA) Specialist

SeniorRegulatory Affairs Specialist RoleSummary

The SeniorRegulatory Affairs Specialist will support the development and execution ofglobal regulatory strategies for medical devices and combination products. Thisrole is responsible for preparing regulatory submissions, maintaining productregistrations, supporting product lifecycle activities, and ensuring compliancewith applicable global regulatory requirements. The position requires closecollaboration with cross-functional teams including R&D, Quality Assurance,Clinical Affairs, Manufacturing, Supply Chain, and Marketing.

KeyResponsibilities

• Support the development andimplementation of regulatory strategies for medical devices andcombination products across global markets.
• Prepare, compile, review, andmaintain regulatory submissions including FDA 510(k), PMA, De Novo, EU MDRTechnical Documentation, and international registration dossiers.
• Perform regulatory impactassessments for product design changes, manufacturing changes, softwareupdates, supplier changes, process changes, and labeling revisions.
• Support product lifecyclemanagement activities by maintaining regulatory compliance and globalmarket registrations.
• Prepare and maintain TechnicalDocumentation, GSPR checklists, compliance matrices, and regulatoryevidence packages.
• Review and update productlabeling, Instructions for Use (IFUs), packaging artwork, UDIrequirements, and marketing materials to ensure regulatory compliance.
• Support regulatory activitiesduring product development, design reviews, risk management, verificationand validation activities, and change control processes.
• Support regulatory strategy anddocumentation activities for combination products.
• Prepare documentation packagesfor internal audits, supplier audits, notified body audits, and regulatoryinspections.
• Maintain regulatory databases,submission trackers, product registration records, and compliancedocumentation systems.
• Conduct regulatory research andsupport assessment of evolving regulatory requirements.

Qualifications& Experience

• Bachelor’s or Master’s degreein Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, orrelated discipline.
• 5+ years of experience inRegulatory Affairs within the medical device or combination productindustry.
• Experience preparing regulatorysubmissions and technical documentation for global markets.
• Working knowledge of FDAregulations, EU MDR requirements, and international medical deviceregulations.
• Experience with regulatorychange assessments, product registrations, and lifecycle managementactivities.

RequiredSkills

• Strong understanding of medicaldevice regulatory requirements and submission processes.
• Knowledge of standardsincluding ISO 13485, ISO 14971, IEC 60601-1, ISO 20417, and ISO 15223-1.
• Strong technical writing,documentation review, and analytical skills.
• Ability to manage multipleregulatory activities and meet timelines.
• Strong collaboration andcommunication skills with cross-functional teams.
• Attention to detail with strongcompliance mindset.