Regulatory Affairs Specialist
Careers that Change Lives
Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations. Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. Responsible for supporting the needs of the MEIC with regulatory support for research and development activities and ensuring Indian and other applicable regulations and policies are met.
A Day in the Life
Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments.
Must Have
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 team member of product development projects from Concept through Commercialization.
Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.
Develop Regulatory Strategies for new or modified products for assigned projects.
Monitor and provide information pertaining to impact of changes in the regulatory environment.
Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
Document, consolidate, and maintain oral and written communication with health authorities
Prepare internal documents for modifications to devices, when appropriate.
Participate in health agency inspections & notified body audits as necessary.
Author and/or review regulatory procedures and update as necessary.
Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information.
Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
Ensure compliance to regulations specific to clearance and approvals of MEIC developed products raw material and/or prototype.
Minimum Qualifications
Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors
4-7 years experiences for RA role in medical device and or pharmaceutical industry
Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.
Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure;
Good at English, including reading, writing, and speaking;
Good Learning attitude
Nice to Haves
Excellent communication and interpersonal skills
Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
Self-motivated and positive
Ability to quickly establish credibility with all levels of customer base