Regulatory Affairs Specialist

Job Description

As a Regulatory Affairs Specialist, you will play a crucial role in navigating the complex regulatory landscape of medical devices. Your expertise will ensure our products meet all regulatory requirements, fostering compliance and innovation. You'll work closely with cross-functional teams to develop and implement effective regulatory strategies.

Responsibilities

• Ensure regulatory compliance for new and existing products by preparing necessary documentation and submissions.
• Work with quality assurance to align regulatory compliance with quality systems.
• Evaluate potential regulatory impacts of product changes and communicate findings.
• Manage relationships with regulatory agencies and facilitate inspections.
• Support clinical trial applications and monitor progress with regulatory bodies.
• Assist in preparing for and participating in meetings with regulatory authorities.

Requirements

Education

• Bachelor's degree in relevant field
• Advanced degree is a plus

Experience

• At least 4 years of regulatory affairs experience in the healthcare or medical device sector.

Technical Skills

• Knowledge of Medical Device Regulations
• Proficiency in Regulatory Software

Soft Skills

• Team Collaboration
• Adaptability

Certifications

• Certified Regulatory Affairs Specialist (CRAS)
• ISO 13485 Certification

Languages

• English: Fluent

Advantageous

• Familiarity with Quality Management Systems: Experience with ISO 13485 or similar quality management systems.
• Previous Interactions with Regulatory Authorities: Experience liaising with FDA or other regulatory bodies.

Benefits

• Flexible working hours and remote work options
• Comprehensive health coverage
• Paid time off for vacations and sick days
• Employee wellness programs and resources

Company Culture

• Innovation: We foster a culture of innovation where creative ideas are encouraged and nurtured.
• Flexibility: We support a work-life balance through flexible scheduling and remote options.
• Employee Engagement: We prioritize employee engagement and satisfaction, ensuring our team feels supported and motivated.