Senior Regulatory Specialist
A senior regulatory specialist is required to join our team. This role will focus on ensuring compliance with relevant regulations and standards across the medical device industry.
Responsibilities:
1. Develop and execute regulatory strategies for product registration, approval, and compliance.
2. Manage day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements.
3. Management of regulatory submissions, including preparation, maintenance, review, and submission of regulatory documents and applications to health authorities.
4. SUPPORT THE TEAM TO OBTAIN / RETAIN COUNTRY-SPECIFIC REGULATORY REGISTRATIONS ON A GLOBAL BASIS.
5. Monitor and ensure compliance with national and international regulatory requirements and quality standards.
We are looking for a skilled professional with expertise in regulatory affairs and a proven track record of successfully managing projects to deadlines.
Benefits:
* Competitive Salary, Bonus, Pension, Healthcare + Excellent opportunity to develop your experience and career in an exciting company.
Job Title: Senior Regulatory Affairs
Location: Bishopstown, Cork
Maintain the highest level of quality within the organisation by assessing overall risk profiles and then creating programs / tools to mitigate potential risk.
Work collaboratively with KARL STORZ to
Logging customer complaints and adverse events
Coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required
Manage CE mark submissions, significant change notifications and Notified Body interactions.