Regulatory Affairs Specialist MDDR

Regulatory Affairs Specialist - IVD/MDDR

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

We are looking for passionate, resilient, and inspiring individuals to join our team. As a Regulatory Affairs Specialist you will be responsible for assembling/preparing technical documents for IVD. You will be working independently but as part of a cross functional team.

The role

• Effectively perform Regulatory Affairs activities on regulatory projects and/or clinical trials being undertaken by ICON Assist the team with study maintenance activities by providing administrative and tracking support
• Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken
• 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

What you need

• Minimum of a Bachelor's degree, preferably in life sciences
• Minimum of 3 years' experience in related field
• Experience in the preparation of regulatory submissions and dossiers
• Ability to read and interpret design and verification documentation
• Prior R&D experience preferred
• Strong written and oral communication skills

Why join us?

Ongoing development is vital to us, and as the Regulatory Affairs Specialist you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin