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Associate Director/Director, Cardiovascular Regulatory Affairs - Remote

Posted 60 weeks ago
Finance / Legal
Full Time
USA

Overview

MCRA is seeking an Associate Director/Director, Cardiovascular Regulatory Affairs to be a critical team member supporting regulatory strategy and submissions for the firm’s cardiac electrophysiology clientele.

In Short

  • Manage the development of regulatory submissions.
  • 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 regulatory strategy for cardiac electrophysiology.
  • Work within a leading medical device advisory firm.
  • Contribute to a dynamic, market-leading effort.
  • Integrate key value-creating functions.
  • Serve a diverse clientele globally.

Requirements

  • Experience in regulatory affairs.
  • Knowledge of cardiac electrophysiology.
  • Strong communication skills.
  • Ability to manage projects and personnel.
  • Experience in mentoring and training.
  • Understanding of healthcare compliance and quality assurance.
  • Ability to work in a fast-paced environment.
  • Strong analytical skills.
  • Experience in clinical research is a plus.
  • Ability to work collaboratively with clients and regulatory bodies.

Benefits

  • Opportunity to work with a leading firm in the industry.
  • Engagement with a diverse range of clients.
  • Professional development opportunities.
  • Collaborative work environment.
  • Potential for career advancement.
  • Access to industry expertise and resources.
  • Supportive team culture.
  • Involvement in innovative projects.
  • Global presence and opportunities.
  • Competitive compensation package.
MCRA logo

MCRA

MCRA, an IQVIA business, is a premier medical device advisory firm and clinical research organization (CRO) that excels in integrating regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance services. With a strong commitment to delivering exceptional value, MCRA supports clients throughout the entire lifecycle of medical device development, from concept to commercialization. The firm boasts a global presence with offices in Washington, DC, Manchester, CT, and New York, NY, as well as operations in Japan and Europe, serving over 1500 clients worldwide. MCRA specializes in various therapeutic areas, including orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.

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