Quality Assurance & Regulatory Affairs Specialist

Location: Bristol  |  Bristol  |  England
Sector: Life Sciences
Consultant: Harvey Havell
Job Reference: HH/H389
Salary: £25000 - £35000
Job Status: Permanent / Full Time

We are looking for a Quality Assurance and Regulatory Affairs person from a technical background to complete our Quality and Regulatory compliance Team.

Responsibilities

  • Refine procedures, instructions, templates when needed
  • Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information, corrective and preventive action forms, PMS, …
  • Train all employees to the QMS, and assess skills, knowledge and QMS application
  • Refine technical documentation necessary to complete a design dossier suitable for submission to our external auditor
  • Perform internal audits to assess the company compliance with our QMS
  • Work with our Notified Body to ultimately achieve award of a CE mark and maintain current certifications
  • Work with external consultants whenever necessary
  • Maintain surveillance of the many relevant quality standards

Personal qualities

  • Ability to prioritise and make decisions.
  • Good problem-solving abilities – able to identify facts, consider a number of alternative approaches and evaluate the most appropriate course of action.
  • Demonstrates a positive attitude to change and contributes to new ideas and improved ways of working.
  • Excellent oral, written, cross functional and interpersonal communication skills that are appropriate for various levels, including management, staff, contractors and clients
  • Good team-working skills including commitment and flexibility
  • Demonstrate sound work ethics.
  • Looks beyond boundaries of own job to support others.
  • Excellent attention to detail and working knowledge of appropriate regulation and good manufacturing practices.

 Experience/qualifications

-Master’s level (biophysics, medical, or engineering are a plus)

-3-5 years of working experience in a regulated sector (healthcare, aerospace, defence)

-Experience in Quality Management System

-Experience in CE-marking or FDA approval is a plus

Details:

-Location: Bristol (with 20% travel for the first 6 months)

-Full time

-Salary: depending on experience £25-35k

About Us

Our company mission is to widen adoption of neuromodulation therapies by:

  • Enabling simpler, safer and shorter Deep Brain Stimulation (DBS) procedures
  • Developing new indication for DBS in treatment of dementia, hypertension and stroke in markets that have a substantial unmet need
  • Developing additional neuromodulation devices based around proven technology

We have a 35-year history manufacturing the SARS implantable device for restoration of bladder and bowel function after severe spinal cord injury and we are developing a deep brain stimulator to treat Parkinson’s disease.  Exciting and rewarding work with leading-edge technology, while also making a genuine contribution to transforming the life of many people.  We are the only company in the UK with clean room manufacturing facilities approved under the Active Implantable Medical Devices Directive (AIMDD) ISO 13485. With a management team of successful entrepreneurs, we are funded by UK government grants and private investors from the medical industry.

 

About Seven

You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.

Are you ready for the challenge? If so, we look forward to hearing from you.

What else can you expect from Seven?

– Specialist Consultant allocated to you with all the expertise you require.

– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.

– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.

– £250 Referral Bonus for every person you successfully refer to Seven.

If you are interested in this opportunity, please call 020 3887 7365. Please ask for Harvey Havell in the Life Sciences team