Job Title: Regulatory Affairs Associate
Location: Aventa Med Rubicon Centre, Bishopstown, Cork
Benefits:
* Competitive Salary
* Bonus
* Pension
* Healthcare
Excellent opportunity to develop your experience and career in an exciting company.
Company Overview:
Karl Storz has developed a breakthrough single-use medical device, Solo+TTD 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.
The surgical tympanostomy is the most common procedure done on children.
About the Role:
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.
Key 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 organisations 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:
o Working collaboratively with KARL STORZ
o Logging customer complaints and adverse events
o Coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required
o 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.
Requirements:
* Bachelors 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 CFR 820 and supporting standards.
* Proven track record with the ability to successfully manage projects to deadlines
* Experience working directly with regulatory agencies