Vice President, MedTech Cardiovascular Regulatory Affairs

About the role

iqvia's MCRA (part of IQVIA MedTech) is looking for a Vice President, MedTech Cardiovascular Regulatory Affairs, to support regulatory strategy and submissions for its clients and to lead the cardiovascular regulatory affairs function. The role covers managing regulatory submissions and strategy, communicating with regulators and clients, and mentoring and training junior staff.

Key responsibilities

• Manage and grow the department, including budgets, client relationships, hiring, training and business development
• Develop and execute regulatory services such as submissions (510(k), IDE, PMA, IND, BLA, technical documentation, STED, CERs), regulatory strategy and pre-clinical testing design and review
• Manage regulatory affairs staff across services and domains, ensuring projects are completed accurately and on time
• Act as primary contact for clients and regulatory bodies, and lead prospecting and business development to secure new clients and projects
• Provide project leadership on complex regulatory projects and collaborate with clinical, RHEMA, compliance and quality assurance teams
• Mentor and train junior employees and lead people development projects

Required profile

• Bachelor's degree in a scientific, engineering or regulatory discipline; MS or PhD preferred
• Minimum 15 years of regulatory affairs experience in medical devices, drugs and/or biologics, including project management
• 3 to 5 years managing people in regulatory affairs or biomedical R&D projects
• US and/or international regulatory experience (FDA, Notified Body, ISO 13485) and domain expertise in a therapeutic area
• Understanding of clinical research and data analysis

Required skills

• Strong written and verbal communication, including medical and technical writing
• MS Office, Excel, Word and PowerPoint
• Research, analytical, critical thinking and problem-solving skills
• Ability to lead teams, handle competing deadlines and work independently

The stated base pay range is $169,200 to $471,500 per year, depending on qualifications, location and schedule; incentives, bonuses and benefits may also apply.