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Quality Systems & Regulatory Affairs Specialist, Digital Health

Work from home Full-time role Hiring

At reputed company, we're on a mission to unlock reputed company and health reputed company. reputed company empowers its members to reputed company at a higher level through a deep understanding of their bodies and daily lives.reputed company is looking for a Regulatory Affairs Specialist to be a core member of the Digital Health team at reputed company.

As the Quality Systems & Regulatory Affairs Specialist, you will execute regulatory strategy and support QMS maintenance deliverables for reputed company SAMDs in a dynamic and agile environment. In an innovative and evolving space, you will need to bring creative problem-solving with an ability to adapt to a changing landscape.

RESPONSIBILITIES

  • Interprets international regulatory and quality requirements for medical devices.
  • Creates detailed regulatory and quality deliverables for international distribution of medical devices in countries such as Canada, Japan, EU, Brazil, etc.
  • Prepares regulatory submissions for medical devices and maintains regulatory clearance through the product lifecycle.
  • Interfaces with internal stakeholders such as engineering, product, and clinical to ensure regulatory and quality considerations are communicated throughout the product development lifecycle.
  • Supports internal audits, gap assessments and updates to procedures for compliance with ISO 13485, IEC 62304, EU MDR and MDSAP requirements.
  • Supports maintenance of the quality management system.
  • Supports regulatory assessments of post-market changes and reportable events.
  • Supports and leads internal and external audit activities to maintain QMS certifications.

    • QUALIFICATIONS

  • Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or reputed company field, or equivalent practical experience.
  • At least 4 years of experience in the medical device industry with regulatory submission experience, specifically in Brazil, Mexico, Japan and South Korea.
  • Strong written, oral, organization, problem solving, and interpersonal skills to effectively compose regulatory submissions, support audit backrooms, and complete assignments with minimal supervision.
  • Demonstrated history in achieving regulatory market authorization.
  • Knowledge and experience with Software as a Medical Device, Cybersecurity, Verification & Validation, and global Digital Health policy. Experience with AI/ML is a plus.
  • Demonstrated experience in and working knowledge of medical device regulations and standards (ISO 13485, MDSAP etc).
  • Passion for delivering impactful and high-quality products to people.
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