Senior Regulatory Affairs Specialist - Medical Devices & Pharma

Our client is seeking a highly experienced Senior Regulatory Affairs Specialist to join their expanding operations in a fully remote capacity, focusing on both medical devices and pharmaceuticals. This role is crucial for ensuring that our innovative products meet the stringent regulatory requirements of global markets. You will lead the development and execution of regulatory strategies, prepare and submit dossiers, and serve as a key liaison with health authorities.

We are looking for a proactive, knowledgeable professional who can navigate complex regulatory landscapes and contribute to the successful market entry and lifecycle management of our diverse product portfolio, working independently and collaboratively in a virtual setting.

• Develop and implement comprehensive regulatory strategies for new product development and lifecycle management.
• Prepare, review, and submit regulatory applications (e.g., PMA, 510(k), NDAs) to relevant health authorities worldwide.
• Maintain regulatory compliance with applicable laws, regulations, and guidelines (e.g., FDA, EMA).
• Liaise effectively with regulatory agencies, responding to inquiries and facilitating communication.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
• Monitor changes in the regulatory environment and assess their impact on the company.

• Bachelor's or Master's degree in a relevant scientific, technical, or healthcare field.
• Minimum of 6 years of experience in regulatory affairs, with specific experience in both medical devices and pharmaceuticals.
• Proven track record of successful submissions and approvals with major regulatory bodies.
• In-depth knowledge of US FDA and/or EU MDR/IVDR regulations.
• Excellent analytical, strategic thinking, and communication skills.
• Demonstrated ability to work independently and manage projects effectively in a remote environment.

• Highly competitive annual salary and bonus structure.
• Comprehensive health, dental, and vision insurance.
• Generous allowance for home office setup and professional development.
• Flexible remote work schedule, fostering work-life balance.
• Opportunity to work on cutting-edge products in a dynamic industry.