
Strategic Regulatory Specialist
1 week ago
Regulatory Affairs Associate Role Overview
">This is an exciting opportunity to develop your experience and career in the medical device industry.
As a key member of our regulatory team, you will be responsible for driving global regulatory submissions, ensuring compliance with standards and regulations, and maintaining our company's reputation as a trusted partner.
Key Responsibilities Include:
- Supporting day-to-day regulatory activities and handling multiple projects related to regulatory compliance enhancements.
- Implementing MDSAP within the organization to ensure effective regulatory practices.
- Working closely with the commercial team and distributors to ensure country-specific registration activities are understood and appropriately addressed.
- Collaborating with interdisciplinary team members to ensure the effectiveness of our quality management system (QMS) and meeting regulatory requirements.
- Supporting internal and external audits, including notified body audits, to maintain our company's compliance and reputation.
- Working with the organization's suppliers to ensure products meet regulatory requirements and comply with CE mark and FDA submissions.
- Providing strategic regulatory insight to team members regarding product development plans and post-market surveillance activities.
- Maintaining daily post-market surveillance activities, including risk management files and process validations.
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