Regulatory Affairs and Clinical Manager

Position Summary:

We are seeking an experienced Regulatory Affairs and Clinical Manager to lead our regulatory and clinical activities. This role is crucial in ensuring compliance with global regulations and overseeing clinical evaluations for our medical device products.

Key Responsibilities:

Regulatory Affairs:

• Develop and implement regulatory strategies for product approvals in various global markets
• Manage the preparation and submission of regulatory documents to health authorities
• Stay current with changes in regulations, particularly EU MDR, and lead company transition efforts
• Coordinate with cross-functional teams to ensure regulatory compliance throughout product lifecycle

Clinical Affairs:

• Oversee clinical evaluation processes, post-market clinical follow-up (PMCF), and clinical investigations
• Develop clinical strategies aligned with regulatory requirements and business objectives
• Manage relationships with clinical research organizations and investigators

Team Leadership:

• Manage and develop a team of regulatory and clinical professionals
• Provide mentorship and guidance to team members
• Collaborate with other departments to ensure alignment of regulatory and clinical activities with overall business goals

Quality and Compliance:

• Ensure adherence to quality management systems and SOPs
• Participate in internal and external audits
• Identify and address compliance issues, conducting investigations when necessary

Requirements

Qualifications:

Education and Experience:

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred
• Minimum of 7 years of experience in regulatory affairs and clinical research in the medical device industry
• Proven track record in successful regulatory submissions and approvals
• In-depth knowledge of EU MDR, FDA, and other global regulations

Skills:

• Strong leadership and team management abilities
• Excellent communication and interpersonal skills
• Analytical thinking and problem-solving capabilities
• Ability to manage multiple projects and priorities
• Proficiency in regulatory submission systems and clinical data management tools

Desirable:

• RAC certification
• Experience with Class III medical devices
• Knowledge of ISO 13485 and 14971 standards

This position offers an opportunity to play a crucial role in bringing innovative medical devices to market while ensuring patient safety and regulatory compliance. The ideal candidate will be a strategic thinker with a passion for advancing healthcare through effective regulatory and clinical management.