Associate, Regulatory Affairs - Medical devices (Raritan)

Associate, Regulatory Affairs - Medical Devices

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative one-team culture. We are looking for a dynamic person to join our in-house team as a Regulatory Affairs Associate (HYBRID) on a permanent basis at Raritan, NJ.

Join our team : you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Responsibilities

• Assist in the planning and tracking of long-term regulatory projects and submission timelines.
• Regularly communicate with clients to understand their needs and proactively address them.
• Coordinate cross-functional team meetings and facilitate communication to ensure project milestones are met.
• Maintain accurate project documentation including project plans, timelines, and status reports.
• Drive regulatory updates and assist in assessing their impact on ongoing projects.
• Contribute to the development and improvement of regulatory project management processes and tools.
• Track project deliverables and resource utilization using appropriate tracking tools to provide direction and support to the project team.
• Identify and escalate issues and potential issues in a timely manner to ensure efficient resolution.
• Provide independent advice on the management of projects based on lessons learned and gained experience.
• Contribute to the preparation of RFI / RFPs / defense bid and act as a guide to the sales and business development team.

Skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture : to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds : gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.