
Regulatory Affairs Lead
2 weeks ago
Regulatory Affairs Lead
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- We are seeking a skilled Regulatory Affairs professional to lead our regulatory strategy in Galway, Ireland.">
- As Senior Regulatory Affairs Program Lead, you will provide expert guidance on International pre-marketing applications and support optimal timelines for new/modified product launches.">
- Key responsibilities include providing independent regulatory guidance to product development teams, defining data and information needed for regulatory approvals, and ensuring compliance with regulatory agency regulations and interpretations.">
Key Qualifications
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- Strong experience in the medical device industry, with some experience in a position in regulatory affairs or related/equivalent field.">
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.">
- Experience of inspection by an external agency, such as the FDA / BSI">
- Ability to work well under deadlines and pressure.">
What We Offer
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- A challenging role in a dynamic environment.">
- Opportunities for career growth and development.">
Why Choose Us?
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- Galway, Ireland is a vibrant city with a thriving tech scene.">
- Our company offers a collaborative and supportive work environment.">
- Competitive compensation package including salary, benefits, and bonuses.">
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