Senior Digital Compliance Manager – Medical Device Software

Location Icon Frankfurt, Germany
Permanent

Senior Digital Compliance Manager – Medical Device Software


Medical compliance can get a little too comfortable. If your job has become a box-ticking exercise with little or no variation from one day to the next, this new, team-building role, focused on a visible high-priority business area (SaMD), will reignite your professional enthusiasm.

This is a new job in a new business unit, building a team equipped to focus on a new area for a global pharma business –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

You’ll lead a new Quality Strategy and Innovation team. 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 company’s digital offshoot.
  • You’ll lead and develop the current three-strong team: developing skills, hiring fresh talent, encouraging agility, and injecting creativity.
  • 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, including a focus on Software as a Medical Device (SaMD) 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 devices. 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 software development cycles and agile ways of working plus a proven ability to lead and influence people. You’re a confident communicator, in writing and in person – if you can do that in both English and German, great.

Initially, you’ll need to be comfortable with working 100% remotely. In time, we anticipate you’ll spend 3-4 days a week in the office and 1-2 days working from home.

About the business

You’ll be part of a global top-20 pharma business with a research-driven focus on innovative therapies that can extend patients’ lives and improve animal health. All in all, it’s a positive, progressive place to work – the ideal setting to develop your career.

Find out more

Start building something new.

To find out more about the business, its brands, and the benefits package on offer, hit the apply button or contact Elliott Pointon;
+447883871556
elliott.pointon@datasciencetalent.co.uk

Enquire today
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