Regulatory Affairs Associate at Life Science Recruitment

Job Description:

Latest job information from Life Science Recruitment for the position of Regulatory Affairs Associate. If the Regulatory Affairs Associate vacancy in Cork matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Life Science Recruitment for the position of Regulatory Affairs Associate below matches your qualifications.

Job Title: Regulatory Affairs AssociateLocation: 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.

Education

• 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

Does this sound like your next career move? To apply, forward your application to the link provided or contact me on R #J-18808-Ljbffr

Job Info:

• Company: Life Science Recruitment
• Position: Regulatory Affairs Associate
• Work Location: Cork
• Country: IE

How to Submit an Application:

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