Description
We are seeking a Vice President, MedTech Cardiovascular Regulatory Affairs to join our team. As a critical team member and company leader, you will support regulatory strategy and submissions for our clients and manage and lead your domain-specific department.
Responsibilities and Duties
- Manage and grow department/team, including budgets, client relationships, employee training and development, hiring, and business development.
- Develop and execute regulatory services for client companies, including regulatory submissions, regulatory strategy, analysis and development.
- Manage Regulatory Affairs staff across multiple services and/or domains, facilitate professional development, and ensure regulatory projects are completed accurately and on time.
- Lead prospecting and be known externally for thought leadership in your area of expertise.
- Lead/manage business development functions to secure new clients and projects.
- Work directly with client companies and/or regulatory bodies as primary contact.
- Provide project leadership on complex regulatory projects while maintaining sole relationship with client companies.
- Collaborate with other MCRA departments, including clinical, RHEMA, compliance, and quality assurance.
- Collaborate with other department heads and executive management to guide progress and development of the regulatory department and company.
Required Knowledge, Skills, and Experience
- Bachelor's degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
- Minimum fifteen years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics, developing regulatory deliverables and submissions.
- Minimum of three to five years of experience managing people related to regulatory affairs or biomedical research and development projects.
- Experience with leadership responsibilities for numerous projects and functioning as primary contact for regulatory bodies and clients.
- Understanding of clinical research and data analysis.
- Possesses US and/or International regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485).
- Domain-specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise.
- Strong attention to detail and ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Strong written and verbal communication and presentation skills.
- Understanding of engineering and biological background to assist with pre-clinical and clinical strategies.
- Ability to creatively think through potential solutions and effectively communicate them.
- Strong research, analytical, critical-thinking and problem-solving skills.
- Strong professionalism with customer relations and managing client relationships.
- Ability to lead small or large teams effectively, mentor junior team members, and be accountable for team reaching target utilization.
- Able to lead multiple projects with competing deadlines; takes initiative and ownership of results; demonstrates a high-level of self-accountability.
- Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
- PC/Technical skills- MS Office, Excel, Word, PowerPoint.
Benefits
The potential base pay range for this role, when annualized, is $169,200.00 - $471,500.00. 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.