Regulatory Affairs Manager

Location: Cambridge  |  Cambridgeshire  |  England
Sector: Life Sciences
Consultant: Life Sciences Team
Job Reference: HH/HH1188
Salary: £55000 - £65000
Job Status: Permanent / Full Time

Regulatory Manager – Technology

The Role

We’re looking for an experience individual to bring regulatory knowledge and rigour to our world leading technology development and product. You will have a passion for detail and excellence, to help us bring the next generation of minimal access, surgical-assist robot to global markets.

You will provide leadership, support collaboration and direction that ensures our submissions are delivered to the highest standard enabling entry into global markets. Your collaborative nature and logical approach will enable you to confidently manage a range of stakeholders across the global business, to ensure successful outcomes are achieved, and innovations embraced.

Responsibilities

Every day will be different and that’s the beauty of joining our rapidly growing team! Some of your primary responsibilities will include:

  • Guiding a multi-disciplinary team responsible for medical device development
  • Focus on pre-market and bringing the next generation product to market
  • Ensuring the implementation of best practice regulatory vision, strategy, policies, processes and procedures to aid and improve business performance
  • Responsible for bridging the gap between the Regulatory and Technology function, ensuring able to communicate efficiently and effectively with the both departments to ensure the right outcome

About you

Success in this role requires:

  • Understanding of complex electro-mechanical devices
  • Leadership and management experience at a senior level: coaching and managing upwards and horizontally
  • Proven track record for bringing technically complex product to market
  • Experience in a multinational highly regulated industry (automotive, aerospace), including full responsibility for RA
  • Working knowledge of medical device related standards / regulations
  • Good working knowledge of risk management and GMP and how it applies to medical devices

The package

We offer a competitive salary and a great benefits package (including bonus, non-contributory pension scheme, cycle-to-work scheme, life assurance). On top of that, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as our commitment to make surgery better for millions of people.