Head of Regulatory Science

This incumbent will be responsible for managing and leading the regulatory program management activities for eMed’s digital health and AI/ML enabled products, including the communications with FDA and other regulatory agencies and complete QMS compliance. The incumbent will build a strong Regulatory Science function to provide strategic assessment of the development pipeline of digital health products and determine the regulatory path forward, to support product development by ensuring timelines of all regulatory deliverables and achieving marketing authorizations for eMed’s development programs.

Requirements

• A degree in a scientific discipline and a minimum of 8 years of healthcare, medical device, pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA in US-based health tech is required for this position.
• Experience achieving regulatory approvals in the digital health space
• Proven experience leading the program management of the regulatory function for digital health organization
• Experience with consumer product development is a plus
• Experience with European regulatory authorities is a plus

Knowledge / Skills / Abilities

• Substantial experience in all aspects of regulatory affairs, including Commercial support, CMC and Clinical, with a track record of successful submissions and license approvals specifically for digital health products
• Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP guidelines and relevant requirements
• A demonstrated ability to manage regulatory activities and deliver against program timelines
• Exceptional qualitative and analytical/quantitative skills
• Demonstrates outstanding leadership capabilities, including employee coaching, objective setting and professional development
• Works with diverse stakeholders and builds strong, collaborative relationships
• Consistently demonstrates strategic thinking about business initiatives with an entrepreneurial spirit
• Exceptional verbal and written communication skills
• Excellent organizational, interpersonal, communication, and negotiation skills
• RAC certification is preferred but not mandatory

Essential Job Functions

• Lead the regulatory program management for successful launch of new digital health products in the US and globally, including regulatory correspondence, submissions, regulatory policy, and go-to-market strategy
• Represent the company before regulatory authorities, leading the US regulatory and quality strategy for digital health, AI/ML products, regulated products and launches, and QMS compliance
• Provide guidance to business development regarding the critical evaluation of potential product opportunities
• Provide regulatory input to the business development group in the assessment of new product acquisition and product out-licensing candidates
• Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide
• Advise and assist in clinical studies required for regulatory approvals, including clinical study design, data analysis, and data reduction
• Direct, control and implement all regulatory activities according to in-house specifications as well as FDA and international regulations
• Provide expert analysis and evaluation of regulatory information
• Provide counsel, training and interpretation of FDA and other regulatory issues to company personnel
• Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures, guidance and regulations
• Prepare, submit and maintain regulatory files (IND, NDAs, supplemental NDAs, etc.) for approved products
• Manage post-market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported during use in the population and prepare/file expedited safety and periodic safety reports to FDA
• Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.
• Oversee the development and management of the regulatory and quality documentation infrastructure

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA) with Company Match
• Life Insurance (Basic, Voluntary & AD&D)
• Unlimited Paid Time Off
• Short Term & Long Term Disability
• Training & Development
• Free Food & Snacks
• Wellness Resources