Job Overview

The Associate Director, Digital Health Business Development is responsible for driving strategic growth within the medical device and digital health market by identifying, developing, and securing consulting and services opportunities across the product development lifecycle. This individual will serve as a trusted advisor to MedTech, software, and healthcare technology organizations, helping clients navigate complex challenges related to connected devices, Software as a Medical Device (SaMD), cybersecurity, human factors engineering, regulatory compliance, clinical evidence generation, and commercialization.

The ideal candidate combines strong business development expertise with technical knowledge of digital health technologies, medical device development, FDA and global regulatory frameworks, usability engineering, and cybersecurity requirements.

Key Responsibilities

• Develop and execute strategic business development plans focused on medical device, diagnostics, digital health, and software-enabled healthcare organizations.

• Identify and close opportunities related to Digital Health Technologies, Software as a Medical Device (SaMD), Artificial Intelligence/Machine Learning-enabled devices, Human Factors Engineering and Usability Validation, Medical Device Cybersecurity, and Clinical Evaluation and Evidence Generation

• Build relationships with executive and technical stakeholders

• Partner with subject matter experts to develop customized client solutions addressing product development, regulatory, clinical, and commercialization needs.

• Lead consultative sales discussions by understanding customer pain points and aligning appropriate service offerings.

• Collaborate with proposal, technical, and operational teams to develop compelling solutions and client presentations.

• Monitor industry trends, emerging technologies, regulatory changes, and competitor activities within the digital health and MedTech landscape.

• Represent the organization at industry conferences, trade associations, and customer events.

• Maintain accurate pipeline management, forecasting, and opportunity tracking within CRM systems.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, Business, or related field.

• 7+ years of business development, sales, consulting, or commercial leadership experience within the medical device, digital health, or healthcare technology industry.

• Demonstrated experience selling technical consulting services, professional services, or development solutions to MedTech organizations.

• Strong understanding of:

  • Medical Device Product Development

  • FDA and Global Regulatory Requirements

  • Human Factors Engineering and Usability Testing

  • Software as a Medical Device (SaMD)

  • Connected Health and Digital Therapeutics

  • Medical Device Cybersecurity

  • Design Controls and Risk Management

  • Clinical and Regulatory Consulting Services

• Proven ability to engage both executive decision-makers and technical stakeholders.

• Strong network within the medical device, digital health, or healthcare technology ecosystem preferred.

• Excellent communication, presentation, negotiation, and relationship management skills.

Preferred Experience:

• Experience working for a medical device manufacturer, digital health company, MedTech consultancy, CRO, testing laboratory, or regulatory consulting organization.

• Familiarity with FDA Human Factors Guidance, IEC 62304, ISO 14971, IEC 81001-5-1, FDA Cybersecurity Guidance, MDR, and IVDR.

• Proven success selling solutions related to human factors, cybersecurity, product development, software validation, clinical strategy, or regulatory consulting.

• Able to credibly engage with engineering, regulatory, quality, clinical, and executive leadership teams while driving strategic revenue growth.

The potential base pay range for this role, when annualized, is $89,900.00 - $250,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.