Regulatory Project Manager

Job content

Proclinical are recruiting a Regulatory Project Manager for a pharmaceutical organisation. This role is on a contract basis and is located in Zug.Responsibilities

• Handle regulatory duties affiliated with the development, assistance, and deployment of the company’s non-medical and medical device software products.
• Supervise and examine both domestic and global regulatory developments, such as Federal Register publication/notices, FDA and EU regulations, etc.) connected to the company’s products.
• Evaluate product labelling to guarantee conformance with suitable regulatory needs and/or approved claims.
• You might serve as a main point of contact for associates to complete global registration of products.
• Serve as a main point of contact with external resources and contacts at multiple management levels regarding operations or scheduling of specific phases of projects.
• Other duties may be assigned to this role.

Key Skills And Requirements

• Educated to a degree level in an engineering or biomedical engineering field.
• At least 5 years of experience within regulatory affairs in a medical device organisation.
• Familiarity with software, SaMD with expertise on software and software development.
• Comprehension of US guidelines and FDA, as well as of EU guidance documents.
• Acquaintance with MDR and proposals for US and EU.
• Capable of engaging and discussing with international health authorities.
• Prior involvement in shareholder management.
• Computer literacy.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 0789542 or p.duvall@proclinical.com.Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.#Regulatory