- Establishing and maintaining a product compliance strategy for products that are offered in geographies such as the US, EU, and Asian markets
- Ensuring consistency and delivery of product and services within the implemented market requirements
- Managing, reviewing, and overseeing the design assurance aspects of product specifications prior to market launch and implementation
- Establishing and overseeing key compliance processes that require timely and effective execution utilizing key indicators and process improvement techniques
- Supporting and guiding product development and manufacturing teams to ensure compliance to applicable requirements and regulations
- Leading the Biofourmis Quality System by championing and /or supporting CAPAs, Internal and external Audits, and Supplier Qualifications elements as needed
- Assisting with risk management activities such as HA, FMEA, and Human Factors, and Cybersecurity as applicable
- Analyzing and supporting root cause analysis and driving continuous improvement
- Guiding teams on computer system validation and assurance
- 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 product development (Pharma and Device), Clinical trials, manufacturing / distribution, regulatory submissions, and quality management in the applicable markets.
- Has the necessary technical, educational, and work experience to become highly knowledgeable with the organizations products.
- 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.
- 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.
- 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, IEC 62304, 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
- Experience with Biotech product development, Clinical trial management, and associated documentation a plus.
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Director of Quality Assurance - Needham, United States - Biofourmis
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 Needham, MA and key offices in Singapore and India. Join our team - we are Committed, Collaborative and are Biofourmis
The Director of Quality Assurance is responsible for developing and implementing the long range regulatory compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis business strategy. This role will report to the Sr. VP of Q&R and will have responsibility for the following customer based solutions globally marketed;
