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Director Quality Assurance and Regulatory Affairs, Americas - Biofourmis

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Job Title
Director Quality Assurance and Regulatory Affairs, Americas
Job Location
Boston, Remote
Job Description

Biofourmis brings the right care to every person, no matter where they are. The company’s AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis’ connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier. Biofourmis is a global technology company enabling care delivery, with headquarters in Boston and key offices in Singapore and India.

The Director of Quality and Regulatory Affairs is responsible for developing and implementing the long range regulatory and compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis remote patient monitoring platforms and pharma partnerships on a global basis. 

Key Areas of Responsibility

Reporting to the Sr. VP of Q&R, the Director will have responsibility for the following aspects of customer based solutions;

  • Establishing and maintaining the product compliance strategy per market requirements
  • Supporting customer sales and business development activities (including sales proposals, contracts, and audits) requiring regulatory guidance and oversight.
  • Leading product submissions, Competent Authority interactions (Q-Subs), and associated regulatory operations and processes.
  • Managing compliance to the requirements established by applicable Regulatory Agencies (Competent Authorities)
  • Ensuring consistency and delivery of product and services within the implemented market requirements
  • Managing, reviewing, and approving finished product and service specifications prior to market launch and implementation
  • Establishing and overseeing key processes that require timely and effective execution
  • Supporting and guiding product development, service, and manufacturing teams to ensure compliance to applicable requirements and regulations.

Job Overview

  • Ensures all products are released to established procedures and meet required policies, regulations, and customer requirements.
  • Provides guidance and support on administrative and operational activities to ensure the effective achievement of business objectives with full quality and regulatory compliance
  • Has broad expertise and unique domain knowledge in the areas of pharmaceutical, software, and hardware development, clinical trials systems and processes, manufacturing / distribution, regulatory submissions, and quality management.
  • Has the necessary technical, educational, and work experience to become highly knowledgeable with the organizations products and services.
  • Regularly interacts with company executives, leaders and customers to collaborate and formulate plans to achieve desired outcomes.
  • Works on complex challenges that require in depth knowledge of quality and regulatory principles and practices.
  • Oversees and ensures proper staff allocation, support and development within departmental budgets.
  • Manages direct staff and personal involvement with broad cross functional teams to deliver high quality propositions and solutions in a compliant and efficient manner.

Minimum Requirements 

  • Typically requires a scientific degree within engineering, data science, computer science, or other relevant technical discipline with 8 years similar experience in regulated industry, 5 years with a Masters, and 3 years with a PhD.
  • Experience with Pharma / Biotech product development, Clinical trial management, and associated documentation.
  • Strong clinical trial knowledge, Decentralized Trials, and GCP/ ICH experience required.
  • Working knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR parts 50 and ICH R2 (GCPs), 803, 806, 812, and 820, ISO 13485, ISO 14971, IEC 62366, EU MDR, Canadian MDR, and ANVISA.
  • 10+ years in a regulated environment such as medical device, pharmaceutical, or other relevant fields.
  • 5+ years of management experience
  • Experience with Software as a Medical Device, IEC 62304 / 82304, Digital Therapeutics, and software development practices a plus

Base salary range for this position is $165,000 to $200,000 based upon experience.

 

 

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Biofourmis Headquarters Location

Boston, MA

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Biofourmis Company Size

Between 200 - 500 employees

Biofourmis Founded Year

2015

Biofourmis Funding Rounds

View funding details
  • Series D

    $20,000,000 USD

  • Series D

    $300,000,000 USD

  • Series C

    $100,000,000 USD

  • Series B

    $35,000,000 USD

  • Series A

    $2,000,000 USD

  • Series A

    $5,000,000 USD

  • Seed

    $500,000 USD

  • Angel

    $1,000,000 USD

  • Angel

    $100,000 SGD

Biofourmis' Investors

Biofourmis' Industries

Biofourmis' Tech Stack