Responsibilities

• Sustaining activities in support of a series of change assessments, some of which will equate to submissions.
• Inform and evaluate any changes.
• Write submissions (manufacturing/process/supplier type of sustaining changes).
• Manage and answer questions (if any) the regulator may have.
• Independently review cross-functional documentation (COs/test documents/other).

Requirements:

• Bachelor’s Degree in related field
• Regulatory Affairs Certification (RAC) highly preferred
• Experience working with medical devices in a regulatory role in industry.
• Experience working directly with notified bodies/FDA is preferred.
• Working knowledge of FDA Regulatory requirements, the EU Medical Device Regulation (EU MDR 2017/745) including technical file requirements (STED or Annex II), and/or with EU In Vitro Diagnostics Directive and Regulations (EU IVDR) required
• Excellent scientific writing and verbal communication skills.
• Ability to identify compliance risks and escalate when necessary.
• Effective interpersonal communication skills – both written and oral
• Experience in PMA submissions is preferred.
• Experience interacting with NB during Technical File review or Audits is a plus.
• Experience working at FDA with medical devices and/or diagnostics is a plus or a prerequisite depending on the role.