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Regulatory Affairs Professional

2 weeks ago

Galway, Galway, Ireland beBeeRegulatory Full time
Job Title: Regulatory Affairs Specialist Job Description:

The role of the Regulatory Affairs Specialist is to ensure compliance with all relevant regulations. This includes maintaining quality systems and related documentation.

This position will support company goals and continuous improvement initiatives. It will also prepare and support vigilance on regulatory data related to medical devices.

Maintaining site Regulatory Affairs compliance based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, AIMD, MDR, CMDCAS, and other International Regulations.

Required Skills and Qualifications:
  • Strong communication skills (written and verbal)
  • Ability to coordinate, plan, and organize
  • Ability to work in a fast-paced environment
  • Excellent attention to detail and organization skills
  • Ability to work to deadlines and on own initiative
  • Computer literate, working knowledge of Excel and Word
  • Experience with USA regulatory requirements and EU MDR requirements would be advantageous
  • Negotiation and strong problem-solving skills
  • Ability to communicate and operate effectively with multiple teams
  • Good technical report writing skills
Benefits:

This role offers the opportunity to work in a dynamic and innovative environment. As a Regulatory Affairs Specialist, you will be responsible for ensuring the quality and safety of medical devices.

You will have the chance to develop your skills and expertise in regulatory affairs and contribute to the success of the company.

This role requires strong communication and organizational skills, as well as the ability to work independently and as part of a team.

We are looking for a highly motivated and detail-oriented individual who is passionate about regulatory affairs and has a strong understanding of medical device regulations.

Others:

This role is a hybrid role that requires the employee to be on-site three days a week.

We are an equal opportunities employer and welcome applications from diverse candidates.