Manager, Regulatory Affairs and Quality Assurance (Medical Device Software) @ 12 Sigma Technologies

Job Type: Full-time

Contact: career@12sigma.ai

Company Overview:

Headquartered in San Diego, California, 12 Sigma Technologies is a well-funded start-up company focused in applying artificial intelligence and deep learning into modern medical image diagnostics and data analytics. We also have R&D, sales, and marketing teams in China. We work closely with our partners in conducting medical diagnostics, technical research and clinical trials. 12 Sigma offers competitive salaries, benefits, and visa sponsorship.

Position Summary:

The Regulatory Affairs (RA) and Quality Assurance (QA) manager will represent RA and QA on cross-functional project teams to provide support and guidance. The manager will implement overall regulatory strategy and quality management system (QMS) to ensure high quality submissions to FDA, in compliance with regulations and guidelines for medical devices, especially for software products.

Responsibilities:

  • Lead, coordinate, author, and review regulatory filing documents

    • Prepares FDA submissions and CE Mark Technical Documentation File, including 510(k) submissions, Device Master files, technical files, and post market surveillance, for product changes and/or new products as required to ensure timely clearance or approvals
    • Reviews clinical study documentation, including clinical protocols, informed consent, and clinical study recruitment materials
    • Collects documentation and coordinates with cross-functional teams to prepare regulatory submissions to regulatory agencies (or commercial partners)
    • Creates and maintains regulatory submission timelines and track deliverables to ensure company goals are met
  • Develop and execute company’s regulatory strategy in the US

    • Develops overall organizational regulatory and strategies
    • Provides strategic input and regulatory advice to project teams on development programs including new product development and changes to existing products
  • Conduct regulatory research and analysis

    • Keeps abreast of current regulatory landscape for medical device globally, e.g., 21st Century Cures Act and related FDA guidance documents, Medical Device Regulations (MDR), EU guidance documents, IEC 62304, AAMI TIR45, AGILE development, and etc
    • Familiar with Software as Medical Device (SaMD) and related regulations and guidance governing product development
    • Develops and communicates recommendations regarding new/emerging regulations to management and project teams
    • Identifies potential project issues proactively to allow implementation of appropriate regulatory strategies to mitigate risks
  • Interact with regulatory authorities

    • Represents the company and works directly with regulatory authorities on regulatory issues and submissions
    • Leads the preparation of responses to questions from regulatory authorities
    • Facilitates the preparation of meetings with regulatory authorities to support regulatory filings
  • Provide in-house training in quality / regulatory guidelines as applicable to team members
  • Supports international RA and QA efforts and collaborates with other teams across the company as needed

    • Manages and modifies a complete and comprehensive quality system to support development of Class II and Class III medical device products
    • Reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
    • Conducts on site audits of various products and processes and host regulatory agency audits as needed
    • Evaluates, authors and reviews SOPs, Guidelines and Work Instructions to ensure regulatory documents, submissions, and systems are well-controlled and comply with applicable regulations

Requirements

  • Regulatory and Quality experience

    • BS Degree or higher along with5- 8 years of related work experience in Regulatory and/or Quality for medical devices and software
    • Demonstrated understanding of laws, regulations, standards, and guidance and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
    • Experience in working with quality aspects of medical device and GMP in general, including implementation of FDA guidance on Cybersecurity Management and Software contained in Medical Device
    • Proven ability to successfully interact with regulatory authorities and manage major submissions and critical projects to meet deadlines
    • Proven track record and experience with regulatory submissions with a thorough understanding of FDA regulations
  • Soft skills
  • Ability to manage and prioritize multiple tasks in a fast-paced environment while keeping with submission timelines
  • Self-motivated, well organized, detail oriented, and has excellent written and verbal communication skills
  • Works under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines
  • Strong leadership skills and experience, a team player, a fully engaged, hands-on professional capable of working collaboratively and independently
  • Computer technical skills

    • Experience with electronic submission building tools, document formatting and publishing standards
    • Experience using electronic document management system (EDMS)

Preferred Qualifications

  • Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be a plus
  • RAC certification will be a plus
  • Experience in medical software development area is desirable but not required
  • Implementation of Regulatory/Quality along with medical device product development and manufacturing experience will be preferred
  • Prior working experience with FDA will be a plus.

Contact: career@12sigma.ai

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