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