Complaints & Vigilance Manager - North London

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Overview:

I am partnering with an industry leading Medical Device organisation to secure a Complaint & Vigilance Manager who will be based on site in North London/Hertfordshire. The Complaint & Vigilance Manager will be managing a team of Complaint & Vigilance Engineers and Post Market Compliance Specialists to provide support to the company's regulatory & compliance processes.

The successful Complaint & Vigilance Manager will be a great leader, team player and an effective communicator who is able to interact with cross functional teams. It is also important that they are analytical and methodical in their approach to work.

The Complaint & Vigilance Manager will report into a QARA Director and have excellent opportunities for training, development and career progression.

Success in this role will require at least 5 years of experience in an FDA regulated Quality role, preferably in complaint management in the Medical Device industry.

Key Responsibilities:

* Manage a team of engineering and scientific professionals and technicians in the complaints and vigilance Department

* Allocate and manage appropriate resources, budgets and timescales to ensure timely delivery of key objectives

* Actively participate with design teams to support manufacturing

* Provide feedback to key stakeholders on device performance for the improvement of the manufacturing processes for existing and new products

* Work closely with key stakeholders to resolve in-house and supplier quality product issues identified through complaints or NC/CAPA process

* Provide technical expertise and support on device performance to the business

* Ensure that compliant and accurate SOPs/WIs are in place.

* Review/approve nonconforming material and system documentation.

* Participate in continuous (breakthrough) improvement activity and process projects in support of the business

* Achievement of strategic goals and annual operating budgets

* Manage the complaint investigation activities

* Effectively manage FSCA activities for the site in line with company requirements.

* Responsible for both supporting PMS and providing data as required by Clinical Affairs

* Manage day to day team activities and requirements

* Organise development plans and support training activities for the team

* Manage the HHE and FSCA activities for the site when and where necessary

Skills & Experience Required:

* Degree or equivalent qualification in engineering, scientific or technical subject

* 5 + years of experience in FDA regulatory environment - ideally Medical Device Manufacturing

* Experience working to FDA QSR, ISO 13485, and the MDD (93/42/EEC)

* Proven experience of leading cross functional teams

* Demonstrated project management skills

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales