Job Title: Senior Regulatory Affairs
Location: Bishopstown, Cork

Benefits: Competitive Salary, Bonus, Pension, Healthcare + Excellent opportunity to develop your experience and career in an exciting company.

Company:
My client have recently been acquired and have developed a breakthrough single-use medical device, that addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear.

Overview:
In this role you will ensure that the company’s products and services comply with all relevant regulations and standards. You will collaborate with cross-functional teams to facilitate the regulatory approval process, manage submissions, and maintain compliance with evolving regulatory requirements. This is an exciting opportunity to be at the forefront of innovation and make a significant contribution to the company's success. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor.

Responsibilities:

• Develop and execute regulatory strategies for product registration, approval, and compliance.
• Manage day-to-day regulatory activities as well as handling multiple projects related regulatory compliance enhancements.
• Management of regulatory submissions, including the preparation, maintenance, review, and submission of regulatory documents and applications to health authorities.
• Support the team to obtain / retain country-specific regulatory registrations on a global basis.
• Manage the implementation of MDSAP within the organisation.
• Monitor and ensure compliance with national and international regulatory requirements and quality standards.
• Identify and assess potential regulatory risks and propose/implement effective mitigation strategies.
• Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes.
• Stay current with changing regulations, guidelines, and industry trends.
• Contribute to maintaining the highest level of quality within the organisation by assessing overall risk profiles and then creating programs / tools to mitigate potential risk
• Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to:
  
  • Working collaboratively with KARL STORZ
  • 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
  • Regulatory trending and reporting activities as required
  • Manage CE mark submissions, significant change notifications and Notified Body interactions.
  • Support the team with the preparation of international regulatory filing, including 510(k) submissions and subsequent FDA correspondence.
  • Review / approve public-facing materials for regulatory compliance
  • Carry out other regulatory-related duties as required.
  
  

• Bachelor’s degree in Engineering or Science with a minimum of 6 years of regulatory experience in the medical device industry.
• Regulatory certifications in EU MDR and US FDA desirable.
• Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, 21 CRF 820 and supporting standards.
• Proven track record with the ability to successfully manage projects to deadlines.
• Experience working directly with regulatory agencies.
• Strong ability to manage critical projects as part of an interdisciplinary team.