Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations
Support the Global Operating Unit Regulatory Affairs function as the local representative, ensuring requirements are met
Provide regulatory support for research and development activities and ensure compliance with Indian and other applicable regulations and policies

A Day in the Life:

Support Design and Development Control activities with regulatory requirements, direction, tactics, and strategies.
Work in a team environment with all organizational departments.

Job Responsibilities:

Prepare, review, file, and support premarket documents for global registrations for assigned projects.
Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization.
Review pre-clinical and clinical protocols and associated reports for submissions.
Develop Regulatory Strategies for new or modified products.
Monitor and provide information on regulatory environment changes.
Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
Document and maintain communication with health authorities.
Prepare internal documents for device modifications.
Participate in health agency inspections and notified body audits as necessary.
Author and/or review regulatory procedures and update as necessary.
Review change control documents and assess regulatory impact.
Assist in the development/maintenance of regulatory files, records, and reporting systems.
Review promotional material, advertising, and labeling for regulatory compliance.
Ensure compliance with regulations for MEIC developed products raw materials and prototypes.

Minimum Qualifications:

Bachelors degree in Medical, Mechanical, Electrical Life Science, or other healthcare-related majors.
4-7 years of experience in a Regulatory Affairs role in the medical device and/or pharmaceutical industry.
Good understanding of regulations and policies issued by India, US FDA, and EU, with the ability to interpret international regulatory requirements.
Excellent written, organizational, and communication skills.
Strong attention to detail and ability to handle multiple tasks.
Proficient in English (reading, writing, and speaking).
Good planning skills and the ability to work under pressure.
Good learning attitude.

Nice to Haves:

Regulatory Affairs Specialist