Business Unit Leader, Devices

Reports To: Chief Executive Officer

Position Summary: 

We are seeking a dynamic and experienced Business Unit (BU) Leader, Devices to oversee and manage our growing medical device regulatory consulting practice. This individual will lead a team of regulatory experts, strategize key business opportunities, and ensure that our clients receive exceptional service in navigating complex regulatory landscapes. The ideal candidate will possess in-depth knowledge of the medical device industry, regulatory frameworks, and client relationship management, with a proven track record in driving business growth. This role is expected to be approximately 65% management and leadership responsibilities and 35% billable/consulting responsibilities.  The BU leader reports directly to the CEO.

The role includes line management of Medical Device team staff, responsibility for all team financial KPIs and providing knowledge, experience, business development support and direction on achieving Company and BU goals. The incumbent will foster a collaborative and team environment, ensuring an overall ‘culture of quality’ in the execution of services provided to clients. The Business Unit Leader is responsible for driving performance, goal attainment and growth strategies. This position requires a balance of client/opportunity oversight, quality management and people management, along with strategic business development and marketing acumen with support of device team members in line with the growth objectives of the Company as defined by Management (65% of time).

Billable/consulting duties (35% time) will include providing direct consultation with medtech as well as pharma and biotech companies to advise them on the best approaches that will expedite product development through marketing authorization.   Responsibilities include, but are not limited to, leading projects, identifying and interfacing with relevant organizations in the medical device industry, preparation for and participation in FDA meetings, and reviewing and/or writing regulatory documents (e.g. 510(k), PMA, IDE, etc.).

The incumbent should have a terminal or advanced degree with at least 10 or more years of experience within industry, consulting, or a national regulatory agency such as the Food and Drug Administration, as well as have experience with a broad base of products (combination, SaMD, AI/ML, cardiovascular, IVD, etc.), possess expert skills in advising on regulatory strategy for device development, clinical trials, labeling, post-market surveillance and quality systems; and have excellent verbal and written communication skills. The qualified candidate will have a minimum of 6 years in a leadership position.  Experience and strong people management skills are requirements for this role. 

Duties and Responsibilities: 

To include the following and other duties as identified and assigned. 

• Lead and mentor a team of regulatory consultants and specialists focused on medical device regulatory compliance 
• Foster a collaborative and results-oriented work environment that encourages professional growth and development
• Establish clear performance goals and deliver regular feedback to team members. 
• Develop and execute an annual strategic business plan for the medical device regulatory consulting practice, ensuring alignment with company goals
• Identify new business opportunities, expand the customer base, and build long-term client relationships
• Monitor industry trends, regulatory changes, and emerging market needs to keep services relevant and competitive
• Serve as the primary point of contact for key clients, providing expert guidance on medical device regulatory strategies
• Lead client presentations, negotiations, and communications to maintain high levels of satisfaction and loyalty
• Develop strategy and implement action plan for capacity planning and growth including recruitment. 
• Work with other team leads to facilitate the timely identification of resources required to support multidisciplinary projects where appropriate
• Manage the overall budget for the team and provide periodic updates to Sr Management
• Review and assess resource and talent requirements within the team in line with growth objectives and provide recruitment/hire recommendations to the COO  
• Collaborate with BD, CFO, CEO and other group leads in identifying best practices for on-boarding, recruiting, staff growth and business development to meet business goals. 
• Assess and share opportunities/issues with the team and convey feedback from group members to Biologics Management
• Display leadership ability including ability to create a positive and collegial culture and motivate the device team to perform effectively
• Serve as a positive, energetic, forward-looking leader for the team

Qualifications; Professional Skills and Experience: 

• Terminal or advanced degree in Life Sciences, Engineering, Regulatory Affairs, or related field
• Minimum of 10 years of experience in the medical device industry, with at least 6 years in a leadership role managing regulatory affairs or consulting for medical devices with a proven track record of performance and business success (i.e., goal and revenue attainment), and recognition as an expert in the field of expertise
• Proven experience in regulatory consulting, strategic planning, and business development within the medical device sector
• Comprehensive knowledge of global medical device regulations and standards (FDA,  IVDR, etc.) with a commitment to staying up to date on global regulatory requirements .
• Strong leadership and team management capabilities with a focus on mentorship and professional development
• Excellent communication and presentation skills, with the ability to interact with senior leadership and clients
• Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent oral and written communication skills, team player, organized analytical thinker with a high level of energy and self-motivation
• Demonstrated versatility in conflict resolution, problem solving, and working effectively as a part of a cross functional organization.
• Strategic thinking and problem-solving skills, with a strong focus on client satisfaction and business growth
• Regulatory Affairs Certification (RAC) and/or PMP or equivalent project management is a plus

 Travel and Work Environment 

Anticipated travel requirements for the position will be approximately 20%. This is a ‘remote work’ position. However, the incumbent will be required to travel to Alexandria, VA headquarters periodically for meetings with Management. 

The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodation(s) may be made to enable individuals with disabilities to perform the essential functions.