Regulatory Project Manager

Vor 4 Tagen

Zug, Schweiz Proclinical Vollzeit

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

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**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.

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.

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