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Regulatory Affairs Manager for Accessories

2 weeks ago

Bengaluru, Karnataka, India Siemens Technology Full time
Responsibilities

The successful candidate for the role of Regulatory Affairs Manager for Accessories will be responsible for ensuring that medical device accessories comply with all necessary regulatory requirements.

This includes managing the quality and compliance of accessories, ensuring that they meet the requirements of EU MDR 2017/745. The Regulatory Affairs Manager for Accessories will also be involved in product lifecycle management, including design and development, post-market surveillance, and clinical evaluation.

The successful candidate will work closely with cross-functional teams, including R&D, design, and regulatory affairs, to ensure that accessories are compliant with applicable regulations.

Key skills and qualifications include:

  • Strong understanding of EU MDR 2017/745 and its application to medical devices and accessories
  • Knowledge of ISO 13485 requirements and its application to both medical devices and accessories
  • Experience in managing documentation and records for both medical devices and accessories
  • Ability to lead and train teams on quality standards required for accessories