Director of Cardiovascular Regulatory Affairs - Remote

Overview

The Director of Cardiovascular Regulatory Affairs will support regulatory strategy and submissions for MCRA’s cardiac Interventional clientele, managing the development of regulatory submissions and communicating with regulatory bodies.

In Short

• Manage regulatory submissions for cardiac Interventional clientele.
• Develop overall regulatory strategy.
• Communicate with regulatory bodies and clients.
• Manage various personnel during projects.
• Act as a mentor and trainer for junior employees.
• Support a dynamic, market-leading effort from concept to commercialization.
• Integrate key value-creating functions in regulatory affairs.
• Work within a leading medical device advisory firm.
• Contribute to the success of over 1500 clients globally.
• Focus on therapeutic areas including cardiovascular and digital health.

Requirements

• Experience in regulatory affairs, particularly in cardiovascular devices.
• Strong understanding of regulatory strategy and submissions.
• Ability to communicate effectively with regulatory bodies.
• Experience in managing teams and projects.
• Mentoring and training experience preferred.
• Knowledge of healthcare compliance and quality assurance.
• Strong organizational and leadership skills.
• Ability to work in a fast-paced environment.
• Relevant educational background in life sciences or related field.
• Proven track record in a similar role.

Benefits

• Competitive salary and benefits package.
• Opportunity to work with a leading firm in the medical device industry.
• Professional development and training opportunities.
• Collaborative and innovative work environment.
• Global presence with opportunities for international collaboration.
• Supportive team culture.
• Engagement with a diverse range of clients and projects.
• Focus on impactful healthcare solutions.
• Access to industry-leading resources and expertise.
• Flexible work arrangements.