Regulatory Affairs Project Manager

Our client is a leading German MedTech manufacturer specializing in high-frequency electromagnetic devices. Their innovative solutions are at the forefront of medical technology, improving patient outcomes and setting new standards in the industry. They are committed to excellence, innovation, and compliance, ensuring their products meet the highest regulatory standards globally.

We are seeking an experienced Regulatory Affairs Project Manager to join their dynamic team. The successful candidate will play a crucial role in ensuring their products comply with international regulatory requirements, with a specific focus on FDA regulations. This is a remote position open to candidates based in Europe.

Key Responsibilities:

• Develop and implement regulatory strategies for high-frequency electromagnetic medical devices.
• Prepare and submit regulatory documentation to relevant authorities, including the FDA.
• Ensure compliance with international regulatory standards, including MDR (Medical Device Regulation) and other relevant guidelines.
• Coordinate and manage regulatory submissions, including 510(k), PMA, and other FDA-related applications.
• Serve as the primary point of contact with regulatory agencies and notified bodies.
• Monitor and interpret regulatory changes and updates, assessing their impact on the company’s product portfolio.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
• Develop and maintain regulatory timelines and project plans, ensuring timely submission and approval of regulatory filings.
• Conduct regulatory risk assessments and develop mitigation strategies.
• Participate in product development meetings, providing regulatory input to ensure compliance throughout the product lifecycle.

Qualifications:

• Bachelor’s degree in a scientific discipline, engineering, or a related field. Advanced degree preferred.
• Minimum of 5 years of experience in regulatory affairs within the medical device industry.
• In-depth knowledge of FDA regulations and submission processes (510(k), PMA, etc.).
• Experience with high-frequency electromagnetic medical devices is highly desirable.
• Familiarity with European MDR and other international regulatory requirements.
• Strong project management skills, with the ability to manage multiple projects and deadlines.
• Excellent communication and interpersonal skills, with the ability to work effectively in a remote, cross-functional team environment.
• Detail-oriented with strong analytical and problem-solving abilities.
• Proficient in English

Benefits:

The position will offer a competitive salary, a comprehensive benefits package, and opportunities for professional growth and development within a dynamic and collaborative work environment.