Senior Regulatory Specialist

5 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

Job Description:
We are seeking an experienced Regulatory Affairs professional to join our team. As a Senior Associate, you will play a key role in ensuring the conformity of our SaMD products with regulatory requirements.

The successful candidate will have excellent communication and analytical skills, with the ability to work independently and as part of a team. They will be responsible for creating and maintaining technical documentation, managing device labeling and advertising claims, and driving regulatory strategy across multiple frameworks.

Key Responsibilities:

  • Ensure SaMD product conformity in accordance with Wysa's QMS before release.
  • Create and maintain technical documentation and declarations of conformity.
  • Oversee and maintain post-market surveillance and vigilance reporting.
  • Serve as the primary liaison with regulatory bodies on submissions, feedback, and incident notifications.
  • Manage device labeling, advertising claims, and technical content for compliance.
  • Drive regulatory strategy across EU MDR, UK MDR, and US FDA frameworks.
  • Maintain compliance with international standards and their applicability.
  • Own the effectiveness of internal and external quality processes.
  • Lead clinical evaluation and post-market surveillance activities.
  • Support SDLC process compliance in collaboration with product and tech teams.

Qualifications & Skills:
We are looking for a highly organized and detail-oriented individual with excellent analytical and writing skills. The successful candidate will have:
  • A minimum bachelor's qualification in any of engineering, science, law, medicine, or pharmacy.
  • 4 to 6 years of professional experience in regulatory affairs and in QMS of SaMD/AiaMD.
  • At least managed one end-to-end QMS to medical device certification of an SaMD device.
  • Experience with standards- ISO 13485, IEC 82304/62304, ISO 14971, Usability engineering, 21 CFR 820.
  • Ability to learn quickly, work independently, and maintain professional skepticism.
  • Ability to work in a fast-paced or rapidly changing environment.
  • Excellent collaborator and communicator.

Benefits:
We offer a competitive salary and benefits package, including opportunities for professional growth and development.

About Us:
We are a dynamic and innovative company committed to delivering high-quality products and services. We value our employees and provide a positive and supportive work environment.

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