Regulatory Affairs Professional
2 days ago
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory group, you will be responsible for ensuring compliance with global regulations and obtaining marketing authorizations for new and modified products.
Key Responsibilities:
- Prepare, review, file, and support premarket documents for global registrations.
- Collaborate with business units and international regulatory affairs personnel to support marketing authorizations.
- Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization.
- Review pre-clinical, clinical protocols, and associated reports for submissions.
- Develop Regulatory Strategies for new or modified products.
- Monitor and provide information on the impact of changes in the regulatory environment.
- Communicate with regulatory agencies and 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 necessary.
- Participate in health agency inspections and notified body audits as required.
- Author and/or review regulatory procedures and update as necessary.
- Review change control documents and assess regulatory impact for external and internal documents.
- Assist in development/maintenance of regulatory files, records, and reporting systems.
Requirements:
- Bachelor degree in Medical, Mechanical, Electric Life Science, or other healthcare-related majors
- 4-7 years' experience in RA roles in medical device and pharmaceutical industries
- Good understanding of regulations and policies issued by India, US FDA, and EU
- Ability to interpret international regulatory requirements
- Excellent written, organizational, and communication skills
- Flexible and team-oriented attitude
- Strong attention to detail and ability to handle multiple tasks
- Good at planning and working under pressure
- Good English language skills, including reading, writing, and speaking
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