Senior Regulatory Affairs Specialist
We are seeking a Senior Regulatory Affairs 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.
Key Responsibilities:
* Technical Documentation Management: Manage technical documentation and ensure compliance with regulatory requirements.
* Regulatory Impact Assessments: Conduct global regulatory impact assessments to identify potential risks and opportunities.
* Procedural Updates: Manage updates to global regulatory procedures to ensure continued compliance.
* R&D Support: Provide regulatory support for R&D projects, including input and approval for new product introductions.
* Problem-Solving: Apply technical solutions to problem-solving and quality improvement projects.
* Technical Writing: Use technical writing skills to clearly describe technical information.
* Change Control: Review and assess change control activities for potential impact on current regulatory filings.
* Regulatory Procedures: Maintain regulatory procedures to ensure continued compliance.
* Quality System Compliance: Ensure continual Quality System compliance by adherence 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 as they relate to registration and commercialization of medical devices.
* Issue Investigation: Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues.
* Regulatory Inspections: Support regulatory inspections at the site as directed.
* Department Liaison: Liaise with other departments to ensure correct supporting data generated and provided in a timely manner.
* Licensing Compliance: Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
* Regulatory Agency Interaction: 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:
* 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.
* Risk Management: 3-4 years' experience in Risk, Clinical, and Biocompatibility – an advantage.
* Technical Writing: Excellent technical writing experience within a medical device environment - essential.
* Attention to Detail: Attention to detail and accuracy – essential.
* Language Skills: Fluent in English, both written and oral - essential.
* Time Management: Ability to work well under deadlines and pressure.
* Problem-Solving: Problem-solving skills for developing creative solutions and meeting objectives are required.
* Coordination Skills: Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook, and Excel).
* Analytical Ability: Excellent analytical ability.
* Task Prioritization: Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management.
About Us:
We are a Medical Device Multinational dedicated to providing high-quality products and services to our customers.