Senior Regulatory Affairs Specialist
Our client, a Medical Device Multinational, is seeking a Senior Regulatory Specialist to develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction.
Role/Responsibilities
* Manage Technical Documentation
* Manage global regulatory impact assessments
* Manage updates to global regulatory procedures
* Provide Regulatory support for R&D projects, input and approval for new product introductions
* Apply technical solutions to problem-solving and quality improvement projects
* Use technical writing skills to clearly describe technical information
* Review and assess change control activities for potential impact on current regulatory filings
* Maintenance of Regulatory procedures to ensure continued compliance
* Ensure continual Quality System compliance by adherence to established and evolving internal requirements
* Serve as RA team member for promotional materials review, experimental designs, data analysis, risk management, and product labeling as they relate to registration and commercialization of medical devices
* Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues
* Support Regulatory inspections at the site as directed
* Liaise with other departments to ensure correct supporting data generated and provided in a timely manner
* Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives
* Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks
Skills/Experience:
* Engineering/Science qualification with 5 years of working within R&D/QA/RA in a medical device environment.
* Minimum of 3 years' experience in R&D, QA/RA, Validations
* 3-4 years' experience in Risk, Clinical, and Biocompatibility – an advantage
* Excellent technical writing experience within a medical device environment - essential
* Attention to detail and accuracy – essential
* Fluent in English, both written and oral - essential
* Ability to work well under deadlines and pressure
* Problem-solving skills for developing creative solutions and meeting objectives are required.
* Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook, and Excel)
* Excellent analytical ability
* Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management.