A global leader in medical technology is seeking a Senior Specialist, Safety Vigilance to oversee regulatory submissions, post-market compliance, and product lifecycle activities. This role requires strong regulatory expertise and cross-functional collaboration to ensure adherence to standards, support audits, and shape strategies for market access and product safety.
Key Responsibilities
- Manage product registrations, renewals, licenses, and regulatory submissions to authorities.
- Ensure promotional and communication materials meet regulatory requirements.
- Oversee post-market obligations, including vigilance reporting and supplemental filings.
- Support audits, inspections, and compliance reviews with regulatory authorities.
- Contribute to regulatory strategy, anticipating risks and shaping solutions.
- Provide compliance guidance to cross-functional teams throughout the product lifecycle.
- Participate in SOP development, training, and continuous process improvements.
Required Skills and Qualifications
Education:
Experience:
- Minimum 2+ years in regulatory affairs or related experience, ideally with medical devices.
- Strong project management, documentation, and organizational skills.
- Ability to interpret and apply complex regulatory requirements.
Language Requirements
- Japanese: Fluent.
- English: Business-level proficiency.
Preferred Skills & Qualifications
- Proven problem-solving mindset with adaptability.
- Effective communication skills in cross-functional and multicultural settings.
- Willingness to take on challenging assignments and expand expertise.
About the Company
Our client is a global innovator in medical devices for surgery, neurotechnology, spine, and orthopaedics. With solutions that impact over 150 million patients worldwide each year, the company drives advancements in healthcare by collaborating with customers globally. They foster a culture of collaboration, continuous improvement, and internal mobility, resulting in high employee satisfaction and career growth opportunities.
Why You'll Love Working Here
- Be part of a market-leading regulatory and safety team.
- High visibility with global and regional leadership.
- Collaborate with international teams across multiple functions.
- Join a respected medical community where your expertise is valued.
- Strong benefits, flexible work arrangements, and remote work options.
Don't Miss Out - Apply Now!
