We are seeking a Senior Regulatory Affairs Specialist to join our team at Medical Device Multinational.
The successful candidate will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction.
As a key member of the Regulatory Affairs team, the Senior Regulatory Specialist will:
* Manage Technical Documentation, ensuring accuracy and compliance with regulatory requirements;
* Manage global regulatory impact assessments, identifying potential risks and opportunities;
* Develop and implement updates to global regulatory procedures, ensuring continued compliance;
* Provide Regulatory support for R&D projects, inputting and approving new product introductions;
* Apply technical solutions to problem-solving and quality improvement projects, driving innovation and excellence;
* Utilize technical writing skills to clearly describe technical information, effectively communicating with stakeholders;
* Review and assess change control activities for potential impact on current regulatory filings, ensuring seamless transitions;
* Maintain Regulatory procedures to ensure continued compliance, mitigating risks and ensuring quality;
* Evaluate Quality System compliance by adhering 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;
* Collaborate 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, ensuring smooth operations;
* 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;
* Negotiate with regulatory authorities during the development and review process to ensure submission approval, as well as during audits to mitigate any potential risks.
To be successful in this role, you will possess:
* An
* 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;
* 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.