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    Director, Regulatory Affairs - Needham Heights, United States - Biofourmis

    Biofourmis
    Biofourmis Needham Heights, United States

    4 days ago

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    Description


    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.

    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.


    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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