Regulatory Affairs Manager

SASMAR is seeking a skilled and experienced Regulatory Affairs Manager to lead our efforts in managing the regulatory landscape for our medical devices and dietary supplements. With a strong presence in personal care and fertility products, including the well-recognized Conceive Plus brand, we are dedicated to bringing innovative products to market while ensuring compliance with international regulatory standards.

In this critical role, you will be responsible for overseeing the regulatory strategies for our medical devices and supplements, ensuring that all products meet the necessary compliance requirements for various markets. You will work closely with cross-functional teams, guiding product development and marketing to ensure regulatory adherence throughout the product lifecycle.

Key Responsibilities

• Develop and implement regulatory strategies for the registration and approval of medical devices and dietary supplements.
• Lead and manage regulatory submissions and maintain product registrations across multiple markets.
• Ensure compliance with applicable regulations and guidelines, including FDA, EMA, and other relevant international bodies.
• Responsible for maintenance and continued improvement of ISO 13485 and ISO 9001 quality certifications.
• Provide expert guidance on regulatory requirements and best practices to internal teams and stakeholders.
• Collaborate with R&D, quality assurance, and marketing teams to ensure that product development aligns with regulatory expectations.
• Monitor and analyze regulatory developments and trends to inform business strategies and product compliance.
• Coordinate responses to regulatory inquiries and inspections, ensuring timely and complete submissions.
• Train and mentor team members on regulatory compliance and processes.
• Maintain comprehensive regulatory documentation and databases.

Requirements

• Bachelor’s degree in life sciences, pharmacy, or a related field; Master’s degree preferred.
• Minimum 5 years of experience in regulatory affairs with specific expertise in medical devices and dietary supplements.
• In-depth knowledge of global regulatory requirements and quality standards, particularly FDA and EMA regulations.
• Proven experience managing regulatory submissions and interactions with regulatory agencies.
• Strong understanding of cGMPs and quality management systems.
• Permission to work in Malta.

Benefits

• Competitive salary of 35000-45000 EUR/year
• English language and multi-cultural work environment
• Private Health Insurance (medical, dental, hospitalisation)
• Career advancement opportunities in stable company
• Modern offices, convenient to public transport.

This position is based at our new villa offices in Ta' Xbiex, Malta.