Regulatory Affairs Specialist (remote)

Job Description Regulatory Affairs Specialist I - 2 years

Location: Remote

Summary

Zi-Medical, Inc. is looking to strengthen our Regulatory Affairs department to support our growing global business. We are looking for Regulatory Affairs Associates, Specialists and Senior Specialists on a part time basis (initially) for both permanent and fixed term contract opportunities. We primary focus on medical device and IVD including combination products and companion diagnostics.

Essential Job Functions

  • Prepares regulatory assessments and/or road maps
  • Prepares submission/compliance strategy documents in line with agreed time frames.
  • Supports the generation of technical documentation and the writing and compilation of technical files.
  • Works with cross functional teams - with senior support - to deliver supporting documentation
  • Reviews and approves labeling and instruction for use.
  • Supports Technical File Audits

Requirements

  • Ideally educated to university degree level, in a science subject or equivalent.
  • Candidates should be experienced within Regulatory Affairs, preferably within the Medical Devices field
  • Regulatory experience or equivalent within a regulatory compliance function within a similar environment
  • Global experience within Regulatory Affairs is highly desirable, in particular China, but also including EUROPE, USA, LATAM and APAC
  • Good interpersonal skills are essential
  • Eligibility to work in the USA
  • Mandarin speaker desired (but not essential)

About Us

Visit our website to learn more at www.zi-medical.com

Applications

If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you. When applying please provide details of current remuneration package along with salary expectations

We continue to actively build an environment where every individual can fulfill their potential and be proud ambassadors for Smith & Nephew, our customers and their patients. We value the diversity of our people and welcome applications from everyone.

Seniority Level: Entry level

Industry: Medical Device