Senior Regulatory Affairs Specialist
We are seeking a Senior Regulatory Specialist to join our client, a Medical Device Multinational. This role will involve developing strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction.
The successful candidate will assist in mentoring and development of staff members as part of the role.
Key Responsibilities
* Manage technical documentation for global regulatory impact assessments and 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 and review and assess change control activities for potential impact on current regulatory filings.
* Maintain regulatory procedures to ensure continued compliance and ensure continual Quality System compliance by adherence to established and evolving internal requirements.
* 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.
* 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 and 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
* An engineering or science qualification with 5 years of working within R&D/QA/RA in a medical device environment.
* A minimum of 3 years' experience in R&D, QA/RA, Validations, and Risk, Clinical, and Biocompatibility (advantageous).
* Excellent technical writing experience within a medical device environment is essential.
* Attention to detail and accuracy are essential, as is fluency in English, both written and oral.
* The ability to work well under deadlines and pressure, and develop creative solutions to meet objectives, is required.
* Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook, and Excel), are necessary.
* Excellent analytical ability and the ability to prioritize tasks and manage several projects and tasks simultaneously are also required.
Salary:
$90,000 - $120,000 per annum based on location and experience.