Senior Regulatory Compliance Specialist

4 days ago

Vellore, Tamil Nadu, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000
Job Overview

We are seeking a skilled professional to implement and maintain our Quality Management System (QMS), ensuring products meet quality, safety, and regulatory standards.

  • This role involves implementing and maintaining a QMS like ISO 13485.
  • The successful candidate will ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
  • This includes creating, reviewing, and controlling technical files, regulatory submissions, quality agreements, and internal procedures.
  • The candidate will also provide QA/RA input and support for design and development activities to ensure compliance from the outset.
  • This position requires participating in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • The successful candidate will monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
  • They will also support the management of supplier quality and compliance.
  • This role involves conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.
Key Responsibilities

This is a dynamic role that requires:

  • Deep knowledge of global medical device regulations and standards.
  • Excellent problem-solving and attention to detail skills.
  • Strong communication skills to coordinate with internal departments and external stakeholders.
  • A Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Prior experience in QA/RA within the medical device industry is an advantage.
Requirements

To excel in this role, you should have:

  • Proven track record in implementing and maintaining QMS.
  • Excellent analytical and problem-solving skills.
  • Ability to communicate effectively with cross-functional teams.
  • Knowledge of medical device regulations and standards.
  • Prior experience in QA/RA within the medical device industry is highly desirable.
About Us

We offer a challenging and rewarding work environment with opportunities for growth and professional development.

If you are passionate about quality and regulatory affairs, we encourage you to apply.

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