Medical Device Regulatory Affairs Specialist
hace 4 semanas
We are seeking a highly skilled Medical Device Regulatory Affairs Lead to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for overseeing key regulatory activities and providing strategic and tactical support on combination product portfolios.
Key Responsibilities:- Develop and implement innovative medical device regulatory strategies for combination products and delivery systems.
- Provide regulatory guidance and advice to development teams, ensuring compliance with global regulatory requirements.
- Prepare and review regulatory design control deliverables, ensuring accuracy and completeness.
- Lead and/or support global filing and lifecycle management activities for device aspects of combination product submissions.
- Contribute to product development planning, including strategies to bridge delivery systems during development and post-approval changes.
- Identify and manage issues and opportunities that impact submissions timelines, ensuring timely communication and resolution.
- Ensure regulatory plans are monitored, progress/variance communicated to Management, and risks highlighted.
- Lead and/or support device-related health authority interactions, ensuring effective communication and resolution.
- Provide regulatory impact assessments for proposed product changes, ensuring alignment with company goals.
- Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed.
- Contribute to internal regulatory processes and procedures for medical devices and combination products.
- Engage with regulatory bodies and industry groups to influence industry standards and regulations, ensuring the company's best interests are represented.
- University degree in a scientific or engineering discipline.
- At least 5 years of relevant medical device and/or combination product regulatory experience required.
- Solid understanding of global regulatory requirements for combination products and drug delivery systems.
- Working knowledge of technical/industry standards related to drug delivery systems.
- Proven experience in drug/device combination product regulatory approvals.
- Demonstrate strategic thinking, initiative, change agent leadership, and risk assessment proficiency.
- Ability to synthesize and critically analyze data from multiple sources.
- Strong interpersonal skills and the ability to deal effectively with various business areas.
- Demonstrate excellent communication and influencing skills, both written and verbal, in English.
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