Regulatory Affairs Associate I

The Regulatory Affairs Associate I will be responsible for preparing technical files and international product master files (e.g. STED), to support global regulatory submissions for the registration of IVD systems (assays, instruments, software).

Primary responsibilities for role:

• Prepare regulatory submissions for applicable foreign regulatory bodies, such as EU Technical Files and STED (and their local equivalents), for registration of in vitro diagnostic and/or biological products.
• Coordinate and prepare responses to deficiency letters or requests for additional information from competent authorities
• Interface collaboratively with partners and local liaisons for management of submissions in foreign countries.
• Prepare technical, quality, manufacturing, and regulatory data and documentation for the purpose of developing foreign regulatory submissions.
• Prepare technical, quality, manufacturing, and regulatory data and documentation for the purpose of developing foreign regulatory submissions.
• Support other regulatory activities, as assigned (e.g. document filing; labeling review; import/export issues; regulatory intelligence).
• Prepare meeting agenda and minutes; Draft and finalize status reports and project highlights; Update submissions and approvals spreadsheets.

Knowledge, Skills and Abilities

• Excellent command of the English language (oral or written). Knowledge of a second foreign language is preferred. Proficiency in Microsoft Office and Adobe Acrobat.

Education

• Bachelor of Science and/or graduate degree in the Life Sciences. Experience in regulatory affairs may substitute for this educational requirement.

Experience

• Minimum 1 year experience
• Minimum 1 year life science, healthcare or diagnostics industry experience
• Minimum 1 year of experience in regulatory affairs.
• Experience working in a regulated environment
• Experience in preparation of STED (standard technical documentation)
• Excellent team player