Senior Regulatory Affairs Specialist
The Senior Regulatory Affairs Specialist will play a key role in developing strategies and submissions for complex projects related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction.
This position will be responsible for managing technical documentation, global regulatory impact assessments, and updates to global regulatory procedures. Additionally, the Sr. Regulatory Affairs Specialist will provide regulatory support for R&D projects, input and approval for new product introductions, and apply technical solutions to problem-solving and quality improvement projects.
The ideal candidate will have excellent technical writing skills to clearly describe technical information, review and assess change control activities for potential impact on current regulatory filings, and maintain regulatory procedures to ensure continued compliance.
The Senior Regulatory Affairs Specialist will also serve as an 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.
Responsibilities:
* Manage Technical Documentation
* Manage Global Regulatory Impact Assessments
* Manage Updates to Global Regulatory Procedures
* Provide Regulatory Support for R&D Projects
* 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
* Maintain Regulatory Procedures to Ensure Continued Compliance
* Ensure Continual Quality System Compliance
* Serve as RA Team Member for Promotional Materials Review
* Work with Quality, Operations, Engineering, and Other Internal Groups
* Support Regulatory Inspections at the Site
* Liaise with Other Departments to Ensure Correct Supporting Data Generated and Provided
* Ensure All Operations Are Fully Compliant with License Details
* Interact and Negotiate with Regulatory Authorities
Requirements:
* 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
* Attention to Detail and Accuracy
* Fluent in English, Both Written and Oral
* Ability to Work Well Under Deadlines and Pressure
* Problem-Solving Skills for Developing Creative Solutions and Meeting Objectives
* Skills that Enable Coordination of Data, Including MS-Office
* Excellent Analytical Ability
* Ability to Prioritize Tasks and Manage Several Projects and Tasks Simultaneously