Job Title: Regulatory Affairs Associate
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 be responsible for regulatory submissions worldwide, annual reporting to the notified body and competent authorities, and maintaining compliance to standards and regulations. You must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry.

Responsibilities:

• Support day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements.
• Assist in the implementation of MDSAP within the organisation.
• Support the team to obtain / retain country-specific regulatory registrations on a global basis.
• Work with the Commercial Team / Distributors, to ensure country specific registration activities are understood and appropriately addressed.
• Work closely with interdisciplinary team members to ensure the effectiveness of the QMS to regulations.
• Work closely with QA for internal and external audits, including notified body audits as required.
• Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions.
• Work with the organisation’s suppliers to ensure the products’ process validations and risk management files are to the standard of regulatory submissions.
• Provide strategic regulatory insight to team members regarding product development plans
• Maintain the day-to-day activities of Post Market Surveillance, including, but not limited 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
  • Regulatory trending and reporting activities as required
  
  

• Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance.
• Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations
• Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs
• Keep abreast of changes in domestic and international regulations and guidelines and advise key staff of compliance/non-compliance with current international regulations, policies and EC directives.
• Support the team with CE mark submissions, significant change notifications and Notified Body interactions.
• Support the team with the preparation of international regulatory filings, including 510(k) submissions and subsequent FDA correspondence.
• Carry out other regulatory related duties as required.

• Bachelor’s degree in Engineering or Science with a minimum of 3 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, US 21 CRF 820 and supporting standards.
• Proven track record with the ability to successfully manage projects to deadlines
• Experience working directly with regulatory agencies