Medical Device Regulatory Compliance Professional

1 day ago

Mysore, Karnataka, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000

Job Role:

  • We are seeking a dedicated Regulatory Compliance Specialist to lead the implementation of our Quality Management System (QMS) and ensure our products meet quality, safety, and regulatory standards.

Key Responsibilities:

  1. Develop and execute strategies for ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.
  2. Create, review, and manage technical files, regulatory submissions, quality agreements, and internal procedures to maintain a robust QMS.
  3. Collaborate with cross-functional teams to provide QA/RA input and support for design and development activities, ensuring compliance from the outset.
  4. Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  5. Maintain vigilance over device performance in the market, investigate customer complaints and non-conformity, and manage reporting requirements.
  6. Lead initiatives to improve supplier quality and compliance, conducting regular audits and assessments as needed.

Required Skills & Qualifications:

  • Regulatory expertise: Deep knowledge of global medical device regulations and standards is essential.
  • Problem-solving & attention to detail: Ability to interpret regulations, document processes, and resolve issues efficiently.
  • Communication skills: Strong coordination and stakeholder engagement capabilities.
  • Bachelor's degree: In a relevant field such as engineering, life sciences, or a related technical discipline.
  • Experience: Previous experience in QA/RA within the medical device industry is highly valued.

About Us:

We are a dynamic organization committed to delivering high-quality medical devices that exceed customer expectations. Our team strives for excellence in regulatory compliance, quality assurance, and customer satisfaction.

What We Offer:

A competitive compensation package, opportunities for professional growth and development, and a collaborative work environment that fosters innovation and teamwork.

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