Director, Cardiovascular Regulatory Affairs Interventional

Director, Cardiovascular Regulatory Affairs

MCRA an IQVIA business is seeking a Director, Cardiovascular Regulatory Affairs to be a critical team member supporting regulatory strategy and submissions for the firm's cardiac interventional clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients. The Director will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.

Position Responsibilities :

Develop and execute regulatory services for client companies, including however not limited to :

• Regulatory Submissions (510(k), IDE, PMA, IND, BLA, & IND)
• Regulatory Strategy, Analysis & Development
• Design, Review & Implement Analytical and Clinical Testing
• Manage junior members of MCRA's regulatory department.
• Assist in business development functions (i.e., provide insight on BD calls, bid defenses, etc.) to secure new clients and projects.
• Work directly with client companies and / or FDA without Director or other leadership oversight.
• Provide project leadership while maintaining sole relationship with client companies.
• Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance.
• Work with other regulatory leadership to help guide the progress and development of the spine team and the regulatory department.
• Technical writing and review of documents and deliverables.
• Represent MCRA at conferences and meetings as needed.
• Complete other duties and projects as assigned.
• Ensure all work products comply fully with standards, policies, and mission of MCRA.

Required Qualifications :

Bachelor's degree in a scientific discipline (engineering, or a heavily technical writing-based curriculum preferred); Master of Science, Master of Science in Engineering, or PhD preferred.

Previous or current agency experience is required.

7+ years of regulatory affairs experience required.

4+ years of cardiovascular medical device experience required. The ideal candidate will have direct experience in one or more of the following device areas : Cardiac Interventional Devices.

Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

Possesses engineering and / or biological background to assist with pre-clinical and clinical strategies and can effectively communicate these strategies to internal team members and clients.

Experience developing and / or reviewing regulatory submissions to the US FDA and / or experience with international regulatory affairs and the regulatory bodies governing them.

Knowledge and experience utilizing research and providing statistical analysis.

Strong research, analytical, critical-thinking, and problem-solving skills.

Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results.

Ability to adapt to a rapidly changing environment and quickly identify new trends and changes specific to the industry.

Strong professionalism with customer relations and managing client relationships.

PC / Technical skills : strongly proficient in MS Office Suite, Excel, Word, PowerPoint.

Excellent oral and written communication skills and presentation skills.

Ability to lead a team and mentor junior Regulatory Team members.

Experience working with C-Level and senior management.

Special Requirements :

Travel : 10% (to the Company's offices and for meetings / conferences / etc.)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

The potential base pay range for this role, when annualized, is $134,800.00 - $250,300.00. 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.