Regulatory Affairs Specialist - MDDR

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Would you like the opportunity to join ICON as a Regulatory Affairs Specialist for our Medical Device & Diagnostics Research team? Apply here to learn more about this role and ICON’s “Own It” Culture!

About the Regulatory Affairs Specialist, ICO (MDDR) at ICON:

Location: Home-based – Anywhere in the US or Canada

At ICON you will effectively manage Regulatory Affairs activities on regulatory projects and/or clinical trials being undertaken by ICON. Your responsibilities will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Biotechnology, Combination Products, In Vitro Diagnostics regulatory affairs but may be concerned with other products. You will work on a range of regulatory issues in which analysis of situations or data requires an in-depth evaluation of diverse factors.

·         Prepare and/or support proposals and bids.

·         Participate in regulatory and/or clinical trial project teams.  Assist with the preparation, writing and filing of appropriate FDA pre-market submission, participates in FDA Pre-Submission Meetings, assist with the preparation of additional data/information requested by regulatory agencies.

·         Plan and track designated project activities including financial tracking

·         Initiate product research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements

·         Contribute to scientific and regulatory documents and communication letters to Regulatory Authorities, in collaboration with Regulatory Project Lead or Functional Experts.

·         Contribute to core regulatory submissions, either alone or in collaboration with Functional Experts. Advise on regulatory aspects of protocols and clinical trials.

·         Contribute to regulatory submissions to support post-market administration/activities, e.g. preparation of variations to product approval either alone or in collaboration with Functional Experts. Support the regulatory assessment of proposed changes. Advise on regulatory aspects of post-market activities

·         Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within ICON

·         Keep the relevant Regulatory Project Lead or designee informed of the progress of project activities at all times

·         Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary.

·         Liaise and work with colleagues from other departments, clients and, Regulatory Authorities as required.

Benefits of working at ICON:

ICON offers an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, bonus plan, and enough time away from work to keep balanced. We provide you and the teams with the tools, innovation and resources to be successful in ensuring utmost compliance, operational efficiencies, and continued growth tracks.

To succeed you will need:

BS degree in Life Sciences; MS preferred or equivalent job experience and minimum of 3 years of regulatory experience (PMA, 510(k), QSR), preferably industry/CRO experience in the Pharmaceutical or Biotech Industry. Knowledge of IVR or MDR required.

What’s Next?

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

We invite you to review our opportunities at www.iconplc.com/careers.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment