Medical Device Compliance Specialist
4 days ago
About the Role:
This is an exciting opportunity to join a dynamic team as a Senior Regulatory Affairs Specialist. In this role, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with global regulations.
- Manage technical documentation, including updates to global regulatory procedures.
- Provide regulatory support for R&D projects, including input and approval for new product introductions.
- Apply technical solutions to problem-solving and quality improvement projects.
- Review and assess change control activities for potential impact on current regulatory filings.
- Maintain 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.
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 - 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.
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