The company
My client is a medical device company who specialise in creating transmural lesions. It is an exciting time for the company as they are looking to grow out their regulatory department! They are seeking a Regulatory Affairs Manager to join their dynamic team!
The role
The primary responsibility of the regulatory specialist is to perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry and maintenance. The position requires a high level of innovative thought and problem-solving skills. Multiple tasks will need to be prioritized and responsibilities delegated to ensure department success. In addition to the above responsibilities, the regulatory specialist is required to interact with multiple departments within the organization as well as regulatory bodies.
Responsibilities
Requirements
My client is a medical device company who specialise in creating transmural lesions. It is an exciting time for the company as they are looking to grow out their regulatory department! They are seeking a Regulatory Affairs Manager to join their dynamic team!
The role
The primary responsibility of the regulatory specialist is to perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry and maintenance. The position requires a high level of innovative thought and problem-solving skills. Multiple tasks will need to be prioritized and responsibilities delegated to ensure department success. In addition to the above responsibilities, the regulatory specialist is required to interact with multiple departments within the organization as well as regulatory bodies.
Responsibilities
- Support and prepare documentation for regulatory submissions and registrations (FDA and EU regulatory entities)
- IDE, PMA, 510(k), Design Dossiers, Technical Files.
- Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files
- Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
- Support communication with FDA and Notified Body representative while preparing responses to deficiency letters and/or questions from regulatory agencies.
- Represent Regulatory Affairs on Engineering & R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
Requirements
- Bachelor’s degree (B.S.) from four-year College or University
- Three (3) years minimum experience in regulatory affairs.
- Current knowledge of FDA Guidelines, Medical Device Directives (93/42/EC), ISO 13485, and standards applicable to company products.
- Knowledge and understanding of Quality and Regulatory concepts and application
- Strong analytical, planning and organizational skills
- Strong interpersonal and communications skills (oral & written)
- Self-starter with ability to work independently under pressure and react quickly to changing priorities
- Proficient in MS Office products.
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything