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Regulatory Affairs Manager at Gold Group

Regulatory Affairs Manager

Gold Group Cambridge, Cambridgeshire, Cambridgeshire Full Time
£55,000 - £65,000 / year
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Regulatory Manager

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 my clients 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

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview
 
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Job ID: 212177045