Medical Device Regulatory Expert

1 day ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time

Device Regulatory Specialist - A Role in Pharmaceutical and Medical Device Development

Job Description

We are seeking a skilled Device Regulatory Specialist to join our team in the design, development, and commercialization of medical device technology solutions. Our organization is focused on delivering innovative healthcare solutions for patients worldwide.

The successful candidate will be responsible for ensuring regulatory compliance with FDA, EU, and ISO standards. This involves maintaining detailed awareness of current regulations and collaborating with cross-functional teams to develop regulatory strategies for combination products and medical devices.

The role requires subject matter expertise in applying global medical device and drug-device combination product regulatory requirements. The ideal candidate will have a strong understanding of quality management systems, including ISO 13485 and 21 CFR Part 820.

Key Responsibilities:

  • Maintain knowledge of FDA, EU, and ISO regulations and guidelines related to medical devices and drug-device combination products.
  • Collaborate with technical regulatory teams to develop regulatory strategies for combination products and medical devices.
  • Lead project teams in their awareness of current regulatory best practices when building device development plans.
  • Provide mentoring and support to the technical regulatory team.
  • Provision of expert advice to the EU regulatory function on device constituent of Drug Device Combination products in accordance with MDR and EMA guidance's.
  • Implement and execute strategies and plans to ensure compliance to regulations, legislations, standards, and regulatory guidelines.
  • Author documents for regulatory submissions, including NDAs, ANDAs, BLAs, MAAs, variations, and other related activities.

Required Skills and Qualifications:

To succeed in this role, you will need:

  • Bachelor's degree in a scientific or engineering discipline (Master's or higher desirable).
  • Proven experience in pharmaceutical and/or medical device development.
  • Advanced knowledge of global medical device and drug-device combination product regulatory requirements.
  • Knowledge of global medical device and drug-device combination product quality requirements.
  • Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment.
  • Experience in leading device program teams in problem-solving approaches to technical regulatory issues.
  • Excellent communication skills, both written and verbal.
  • Strong team player willing to take on and support other activities outside core expertise as required.

Benefits:

We offer competitive salaries, benefits, and an inclusive work environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others. Some of our benefits include:

  • Excellent career progression opportunities.
  • Work-life balance initiatives.
  • Bonus scheme.
  • Health insurance.
  • Pension.

About Us:

We are dedicated to building a truly diverse, inclusive, and authentic workplace where everyone can contribute and thrive. If you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

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