Principal Regulatory Affairs Specialist
Principal Regulatory Affairs Specialist
The DAVIS Companies is supporting a global leader in the medical device industry by identifying a Principal Regulatory Affairs Specialist to join their team.
Responsibilities of Principal Regulatory Affairs Specialist:
- Provide the overall regulatory strategy and guidance to project teams and other departments as assigned to ensure achievement of business objectives and government compliance. This individual proactively evaluates existing and emerging regulatory and quality requirements and directs implementation activities to minimize business exposure and guidance for interactions with government officials. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies.
- Ensure that compliance to standards, pre-clinical and clinical study designs meet regulatory requirements.
- Maintain all regulatory files, both hard and electronic copies, ensuring documentation, registers, directories and lists are complete and up-to-date.
- Support for requests from Corporate Registrations Team for global growth and expansion.
- Pre-launch checklists for new and existing products to ensure compliance with internal company requirements and compliance with regulatory requirements.
- Provide strategic product direction to product teams and cross functional partners to advise on global medical device regulation.
- Communication with government regulatory agencies and Notified Bodies and serve as regulatory liaison on the project team throughout the product lifecycle.
- Essential Requirements Checklists, Design Dossiers, Technical Files and Declarations of Conformity for all CE Marked products.
- Manage multiple simultaneous global projects with cross functional teams.
- The Manager and/or Director of Regulatory Affairs may assign other duties, i.e., training, documentation, etc.
- Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
- This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001,MDD 93/42/EEC and government occupational health and environmental regulations and statutes.
- Review of device labeling in all forms and advertising materials for compliance with FDA submissions and applicable regulations; analyze and recommend
- Ensure compliance with regulatory requirements at all times.
- Prepare and conduct meetings/teleconferences with external regulatory agencies as directed.
- Participate as regulatory representative on project teams, communicate regulatory requirements and strategy.
- Develop regulatory plans and departmental positioning in collaboration with the Manager and Director of Regulatory Affairs and Design Assurance.
- Prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and
- Review and ensure regulatory compliance of internal operational and project documentation and all applicable technical standards involved in product
development and commercial product release for all assigned projects.
- In collaboration with senior regulatory representative, prepare and communicate project regulatory strategy.
- Monitor project time-lines and assist in coordination of timely regulatory processes, documentation.
- Review, edit and provide internal regulatory approval signature for project documentation as the active regulatory representative on project teams.
Technical Knowledge and Skills of Regulatory Affairs Specialist:
- Excellent written and oral communication, technical writing and editing skills.
- Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.
- Excellent technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology.
- RAPS Professional Certification (RAC) required.
- Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required.
- Ten to twelve years direct experience in regulatory
affairs in the medical device/drug or biomedical area.