Regulatory Compliance Specialist

2 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €120,000
Job Summary

We are seeking a seasoned Regulatory Affairs professional to lead our regulatory strategy and ensure compliance with evolving requirements.

The ideal candidate will have a strong background in medical device regulations, excellent organizational skills, and the ability to thrive in a dynamic environment.

About the Role

This is an exciting opportunity for a highly motivated individual to take on a leadership role in our Regulatory Affairs team. The successful candidate will be responsible for:

  • Developing and implementing regulatory strategies for new product introductions and ongoing support.
  • Managing global product registrations and ensuring timely submissions to regulatory authorities.
  • Providing strategic advice and guidance on all regulatory matters.

The selected candidate will have the opportunity to work closely with cross-functional teams, including Quality Assurance and Engineering, to ensure seamless collaboration and effective implementation of regulatory requirements.

Requirements

To be considered for this role, you will need:

  • A Bachelor's degree in Engineering, Life Sciences, or a health-related field.
  • 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
  • In-depth knowledge of US FDA and EU medical device regulations (including MDR).
  • Proven track record of managing complex regulatory submissions and interactions.
  • Excellent communication and interpersonal skills, with the ability to build strong relationships with stakeholders.
  • A self-starter with a hands-on approach and the ability to adapt to changing priorities.
What We Offer

As a valued member of our team, you can expect:

  • A competitive salary and benefits package.
  • Ongoing training and development opportunities to enhance your skills and knowledge.
  • A dynamic and supportive work environment that fosters collaboration and innovation.
  • The chance to make a meaningful contribution to the success of our company.

We are committed to providing a workplace that is inclusive, respectful, and free from discrimination. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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