As a senior regulatory affairs specialist, you will play a pivotal role in ensuring compliance with regulatory requirements and developing strategies for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction.
The successful candidate will have the opportunity to work on a variety of tasks, including managing technical documentation, global regulatory impact assessments, and updates to global regulatory procedures. Additionally, they will 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, 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.
You will 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. You will also 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, and ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
To be successful in this role, you will need to have excellent technical writing experience within a medical device environment, attention to detail and accuracy, fluency in English, both written and oral, ability to work well under deadlines and pressure, problem-solving skills for developing creative solutions and meeting objectives, and skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook, and Excel).