Job Description
Senior Regulatory Affairs Specialist - Medical Device Multinational
Key Responsibilities
* Technical Documentation Management: Oversee and manage technical documentation for regulatory compliance.
* Global Regulatory Impact Assessments: Conduct assessments to determine global regulatory impacts on projects and initiatives.
* Regulatory Procedure Updates: Ensure updates to global regulatory procedures are implemented effectively.
* R&D Project Support: Provide regulatory support for R&D projects, including input and approval for new product introductions.
* Problem-Solving and Quality Improvement: Apply technical solutions to problem-solving and quality improvement projects.
* Technical Writing: Utilize technical writing skills to clearly describe complex technical information.
* Change Control Activities: Review and assess change control activities for potential impact on current regulatory filings.
* Maintenance of Regulatory Procedures: Maintain regulatory procedures to ensure continued compliance.
* Quality System Compliance: Ensure continual Quality System compliance by adhering to established and evolving internal requirements.
* RA Team Collaboration: Serve as an RA team member for promotional materials review, experimental designs, data analysis, risk management, and product labeling related to registration and commercialization of medical devices.
* Regulatory Issue Resolution: Collaborate with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues.
* Support during Regulatory Inspections: Support Regulatory inspections at the site as directed.
Requirements
* Qualifications: Engineering/Science qualification with 5 years of working within R&D/QA/RA in a medical device environment.
* Experience: Minimum of 3 years' experience in R&D, QA/RA, Validations; 3-4 years' experience in Risk, Clinical, and Biocompatibility – an advantage.
* Skills: 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, coordination of data (MS-Office), excellent analytical ability, and ability to prioritize tasks and manage several projects simultaneously.
Estimated Salary
$90,000 - $110,000 per annum