Regulatory Affairs Manager/ivd

vor 3 Wochen

Rotkreuz, Schweiz Coopers Group AG Vollzeit

**Regulatory Affairs Manager/IVD**

In this role you will manage activities associated with regulatory approval of** in vitro diagnostic medical device**s.

You will be responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Additionally, you are responsible for assessment of device changes for regulatory implications.

**Responsibilities**:

- Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
- Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.
- Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
- For CDx or Lifecycle Support areas have responsibility for creation and submissions of US FDA pre-submissions, 510(k)s andPMAs for assigned projects.
- Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
- Interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
- Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs

department.
- Serves as Functional Lead on project team.

**Requirements**:

- Degree in a science, engineering, or related technical field
- 3-5 Experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device.
- Experience with regulatory submissions including IDE, 510(k), and PMA submissions.
- Fist experience for CDx with submissions for: IND, NDA/BLA or pharma exp.

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