Vice President, Digital Health and Device Quality Development (REF9145E)

Job Description

The Vice President, Digital Health and Device Quality Development is responsible for leading unique software considerations associated with FDA-regulated medical devices. This includes pure medical devices regulated by FDA’s CDRH, as well as the device component of combination products (CDER and CBER). The job entails providing strategic input necessary for Regulatory Strategy deliverables as well as formal FDA interactions, i.e., submission, meetings, etc. The Senior Consultant, Medical Devices Vice President, Digital Health and Device Quality Development will interface with clients on medical device matters and serve as the point person on assigned projects.

• Lead for projects that involve unique software considerations and necessary input on quality system considerations.
• Assist with activities related to FDA medical device and combination product regulatory compliance, including pre-clearance testing, required clearances and approvals, compliance with quality systems regulations.
• Coordinate and balance priorities of various stakeholders (corporate, scientific, clinical) in the context of regulatory requirements, through active participation in Product Development Teams.
• Provide critical review of all documentation supporting regulatory applications.
• Manage and ensure timely preparation and filing of organized and scientifically valid submissions to FDA.
• Plan, coordinate, and prepare for meetings and teleconferences with FDA.
• Develop and implement effective strategies to ensure necessary regulatory approval to bring products to market with optimum cost-effectiveness and compliance.
• Provide expertise in translating regulatory requirements into effective plans.
• Support new product development efforts, including interfacing with client development team(s) and/or contract organizations.
• Assist with business development to win new business.

Qualifications

• 10+ years in positions of progressive leadership in Regulatory Affairs within regulated medical device or drug development organization.
• 8+ years in a regulatory affairs department on FDA regulatory submissions (PMAs, IDEs, De Novos, 510(k)s, 513(g)s).
• Ability to engage with FDA in resolving issues with submissions, including preparation and submission of successful investigational and marketing applications.
• Solid understanding of multiple routes to clearance or approval of medical devices and combination products.
• Solid understanding the Quality System Regulation (QRS) for devices (21 CFR 820) and cGMP for combination products (21 CFR 4).
• Excellent working knowledge and application of Quality and Regulatory standards.
• Demonstrated ability to manage multiple and diverse projects concurrently.
• Demonstrated ability to develop positive relationships and collaborations.
• Excellent oral and written communication with cross-functional collaboration skills.
• Strong analytical skills; a strategic thinker, planner and implementer.
• Master’s degree in Life Science or Engineering discipline
• Higher degree preferred
• Experience leading teams of technical professionals.

Additional Information

Candidates must be legally eligible to work in the United States.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.