Regulatory Affairs Specialist- Medical Devices

2 weeks ago

Dublin, Dublin City, Ireland ICON Full time

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

The role:

Regulatory Consulting Services (RCS) – Regulatory Affairs for Medical Devices (RAMD)

In the RCS group, a medical device regulatory specialist is a regulatory professional who provides regulatory guidance, classifications, strategies, registrations, submissions, and ongoing support to medical, wearable, in-vitro, digital therapeutic, and combination devices throughout the product lifecycle including post-market support. The regulatory specialist will work with external and internal customers, ensuring regulatory compliance.

Importance of this role to ICON

Offering regulatory to ensuring our clients successfully place their devices on global markets in compliance with all applicable regulations and standards, right-sizing the regulatory process to maximize client's time to market and compliance to applicable regulations and standards.


• Duties will be focused on supporting the In Country Caretaker Service in the EU and UK and medical device regulatory projects. These will fall with medical device Regulatory Affairs but may be in other related areas.

• As member of the Medical Device Regulatory team, will contribute to:
- management of ICC services, contract administration, client documentation, client regulatory audit support,

• Preparation, compilation and submission of medical device premarket applications.
- medical device vigilance reports for ICC customers

• Input to the Reg Intel function

• will work with the ICC support team and the ICON, Authorized Rep

• May work either as part of a device regulatory project team as needed

• May support business development activities

Duties

  • Provide regulatory support as part of a project team, working with external customers and internal ICON divisions on medical device-related projects and trials, in compliance with applicable regulations and standards/
  • Researching and identifying applicable regulations and standards in the US, EU, UK, and other geographies as needed.
  • Build and maintain strong partnerships with customer, addressing customer issues and concerns on regulatory matters.
  • Prepare, compile and file regulatory submissions to regulatory agencies.
  • Interact with regulatory agency personnel as needed to expedite approval of submissions and applications.
  • Work independently and manage multiple project activities under fixed timelines.
  • Participate in inspection/audit activities and following up on any required actions assigned.
  • Represent regulatory affairs in cross-functional project teams and plans schedules for regulatory results on a project and monitors project through completion.
  • Create and implement quality systems improvements.
  • Ensure compliance records are properly maintained.
  • Maintain and update documentation, processes, and practices.
  • Coordinate regulatory compliance procedures across organizational structures.
  • Provide training in compliance practices and procedures.
  • Keeping up to date on regulatory changes and developments in the regulatory environment.

Previous Experience

Essential

  • Scientific Bachelor's degree (any science discipline) Prior experience with one or more of the following:
  • Device manufacturer
  • Notified Body
  • Regulatory Agency
  • Regulatory Consulting Company
  • Minimum of 2 years experience with regulatory services for medical, wearable, in-vitro, digital therapeutic, and combination devices during all lifecycle phases, from pre-market through design and development, trials and studies, submissions, implementation and post-market support

Highly Desirable

  • 21CFR and ISO 13485 Quality System experience
  • Human Factors and Risk Management
  • Work as a member of a small but highly experienced team, contributing to medical device consulting projects and growing regulatory expertise.

Skills

  • Strong verbal and written communications
  • Teamwork
  • Ability to work as a member of a small but highly experienced team, contributing to medical device consulting projects and growing regulatory expertise.

Benefits of Working in ICON:

Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.


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