Regulatory Affairs Specialist Position at Medtronic-Apply before 30th August, 2024

About Medtronic

At Medtronic, we push the boundaries of technology, therapies, and services to alleviate pain, restore health, and extend life. Our team is dedicated to making tomorrow better than today. We are committed to creating meaningful innovations and addressing universal healthcare needs to improve patients’ lives. Help us shape the future.

Position: Regulatory Affairs Specialist-II

Job Description

As a Regulatory Affairs Specialist-II, you will support design and development control activities with regulatory requirements, direction, tactics, and strategies, working in a team environment with all organizational departments.

• Premarket Document Management: Prepare, review, file, and support premarket documents for global registrations for assigned projects.
• Collaboration: Work with business units and international regulatory affairs personnel to support marketing authorizations for assigned projects.
• Product Development: Represent Regulatory Affairs as a team member in product development projects from concept through commercialization.
• Protocol Review: Review pre-clinical and clinical protocols and associated reports for submissions for assigned projects.
• Regulatory Strategy Development: Develop regulatory strategies for new or modified products for assigned projects.
• Regulatory Environment Monitoring: Monitor and provide information on changes in the regulatory environment.
• Agency Communication: Communicate with regulatory agencies and notify bodies on administrative and routine matters.
• Documentation: Document, consolidate, and maintain oral and written communication with health authorities.
• Internal Documentation: Prepare internal documents for modifications to devices when appropriate.
• Inspections and Audits: Participate in health agency inspections and notified body audits as necessary.
• Procedure Authoring: Author and/or review regulatory procedures and update as necessary.
• Change Control: Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
• File and Record Maintenance: Assist in the development and maintenance of regulatory files, records, and reporting systems for systematic retrieval of information.
• Compliance Review: Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
• Material and Prototype Clearance: Ensure compliance with regulations specific to the clearance and approvals of MEIC-developed product’s raw material and/or prototype.

Candidate Profile

• Education: Bachelor’s degree in Medical, Mechanical, Electric Life Science, or other healthcare-related majors.
• Experience: 4-7 years of experience in a Regulatory Affairs role in the medical device or pharmaceutical industry.
• Regulatory Knowledge: Good understanding of regulations and policies issued by India, US FDA, and EU, with the ability to interpret international regulatory requirements.
• Skills:
  • Excellent written, organizational, and communication skills.
  • Flexible and team-oriented attitude.
  • Strong attention to detail and ability to handle multiple tasks.
  • Good planning skills and ability to work under pressure.
  • Proficiency in English, including reading, writing, and speaking.
  • Good learning attitude.
  • Excellent communication and interpersonal skills.
  • Self-motivated and positive.
  • Ability to quickly establish credibility with all levels of the customer base.

Additional Information

• Experience: 4-7 years
• Location: Hyderabad
• Industry Type: Pharma / Healthcare / Clinical Research
• Functional Area: Regulatory Affairs
• End Date: 30th August 2024

Join our team at Medtronic and be part of a company that is dedicated to making a difference in the world of healthcare.

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