Regulatory Affairs Specialist

• 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:

• Excellent communication and interpersonal skills.
• Self-motivated and positive attitude.
• Ability to quickly establish credibility with all levels of the customer base