Senior Digital Compliance Manager (Medical Device) – Hybrid (home & occasional travel to the office)

Location Icon Hybrid (home & occasional travel to the office)
Permanent

Senior Digital Compliance Manager (Medical Device) – Hybrid (home & occasional travel to the office)


This is a new job in a new business unit, building a team equipped to focus on a new area for an international pharmaceutical company – the Software as a Medical Device (SaMD) market.

For someone whose experience spans SaMD and medical compliance/QA, this is an unmissable opportunity to do something refreshingly different. You’ll have the individual freedom here to make a visible impact on a vital new business venture.

 

Your challenge

As part of the progressive pharma business, you’ll lead on the quality and compliance processes for the new SaMD business unit. It’s a chance to shape a function from the very beginning; a role with plenty of autonomy:

  • You’ll design and implement the Quality Management System for SaMD products on a global scale.
  • You’ll help the business make the leap from a traditional pharmacy-driven approach to the more dynamic, agile culture required by SaMD teams working in the digital lab.
  • You’ll have ownership of QA and regulatory compliance for all SaMD products. This untapped area is a commercial priority, so you’ll be making a very noticeable contribution to the business.

Beyond that, the medical solutions you help facilitate could impact millions of lives worldwide. There’s huge potential here, for both human and animal health, so there’s great scope for you to keep learning and progressing.

 

What you can add

Alongside strong experience in the pharmaceutical or medical device industry, you’ll ideally have worked with digital or software products previously, and it’s likely that you have a Doctorate or Master’s degree in a field related to Chemistry, Pharmaceuticals or Engineering.

You’ll need expertise in QA and regulatory compliance of medical device software. That includes ISO 13485 & CFR 820; international GMP and Computerized System Validation & Compliance (CSV&C).

To help build a bridge from the old way of working to the new, you’ll call on your knowledge of the software development life cycle and agile ways of working, plus a proven ability to lead and influence people. You’re a confident communicator, in writing and in person.

 

About the business

here’s arguably nowhere better to pursue a new venture like this. This top-20 global pharma business has been family-owned for more than 100 years. It’s given them the freedom to pursue long-term, sustainable solutions on their own terms, rather than chasing short-term shareholder gains.

Nowhere is this more apparent than in the company’s digital incubator, where leaders are encouraged to explore how digital innovations can be leveraged to accelerate the development of better healthcare for humans and animals.

 

Find out more

Click the enquire today button to find out more about the business, its brands, and the benefits package on offer.

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