Senior Regulatory Affairs Specialist
Our client, a Medical Device Multinational, is seeking a Senior Regulatory Specialist to develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction. The Senior Regulatory position will assist in mentoring and development of staff members as part of the role.
Role/Responsibilities:
1. Manage Technical Documentation: Oversee the creation, maintenance, and dissemination of technical documentation to ensure accuracy and compliance with regulatory requirements.
2. Manage Global Regulatory Impact Assessments: Conduct thorough assessments of global regulatory requirements and impacts on product development, ensuring alignment with company policies and procedures.
3. Manage Updates to Global Regulatory Procedures: Develop, implement, and maintain up-to-date global regulatory procedures to ensure continued compliance and effectiveness.
4. Provide Regulatory Support for R&D Projects: Collaborate with R&D teams to provide regulatory guidance and support for new product introductions, ensuring compliance with regulatory requirements.
5. Apply Technical Solutions to Problem-Solving and Quality Improvement Projects: Utilize technical expertise to identify and implement solutions to quality improvement projects, ensuring alignment with regulatory requirements.
6. Use Technical Writing Skills: Employ technical writing skills to clearly describe technical information, ensuring accurate and concise communication.
7. Review and Assess Change Control Activities: Evaluate change control activities for potential impact on current regulatory filings, ensuring compliance with regulatory requirements.
8. Maintenance of Regulatory Procedures: Ensure continued compliance by maintaining and updating regulatory procedures to reflect changes in regulations and industry standards.
9. Ensure Continual Quality System Compliance: Adhere to established and evolving internal requirements to ensure ongoing quality system compliance.
10. Serve as RA Team Member: Participate in promotional materials review, experimental designs, data analysis, risk management, and product labeling as they relate to registration and commercialization of medical devices.
11. Work with Internal Groups: Collaborate with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues.
12. Support Regulatory Inspections: Provide support for regulatory inspections at the site as directed.
13. Liaise with Other Departments: Facilitate communication between departments to ensure correct supporting data generation and provision in a timely manner.
14. Ensure Compliance with License Details: Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
15. Interact with Regulatory Authorities: Engage with regulatory authorities during the development and review process to ensure submission approval and mitigate potential risks.
Skills and Experience:
* Engineering/Science Qualification: Hold an engineering or science qualification with 5 years of working experience within R&D/QA/RA in a medical device environment.
* Minimum 3 Years' Experience in R&D, QA/RA, Validations: Possess minimum 3 years' experience in R&D, QA/RA, validations.
* Experience in Risk, Clinical, and Biocompatibility: Have 3-4 years' experience in risk, clinical, and biocompatibility, which is an advantage.
* Technical Writing Experience: Possess excellent technical writing experience within a medical device environment.
* Attention to Detail and Accuracy: Demonstrate attention to detail and accuracy.
* Fluent in English: Be fluent in English, both written and oral.
* Ability to Work under Deadlines: Exhibit ability to work well under deadlines and pressure.
* Problem-Solving Skills: Possess problem-solving skills for developing creative solutions and meeting objectives.
* Coordination of Data: Demonstrate skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook, and Excel).
* Excellent Analytical Ability: Possess excellent analytical ability.
* Task Prioritization: Exhibit ability to prioritize tasks and manage several projects and tasks simultaneously.
The estimated salary for this position is $120,000 - $150,000 per annum, depending on location and experience.