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Regulatory Affairs Manager

Regulatory
Ref: 320 Date Posted: Friday 02 Aug 2019
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A global, leading manufacturer of optical and digital precision technology, our client provides innovative solutions for state-of-the-art medical systems. They focus on improving patient care quality every day, by developing and designing world-leading, clinically-advanced, precision technologies and services. Their products enable healthcare professionals, from a broad range of specialties, to ‘peer’ inside the body, using endoscopic procedures, which allows professionals to see more and do more. By focusing on the early detection and minimally invasive treatment of a broad range of diseases, our client’s mutual mission is to improve patient outcomes, minimise discomfort and accelerate the recovery process. Their innovative technologies and services can also optimise workflow and maximise on operational efficiency.

 

On behalf of our global client, we are looking to recruit an Regulatory Affairs Manager on a permanent basis located at heir Southend-On-Sea facility, to ensure the appropriate licensing, marketing and legal compliance of Medical and Industrial manufactured products.

 

 

 

Principal Responsibilities:

 

  • Ensuring continued compliance to all relevant regulatory and quality requirements
  • Timely identification and co-ordination of regulatory changes to ensure no negative impact on the business.
  • Successful completion of mandatory training
  • Compliance with Health & Safety and Environmental procedures.
  • Certification management with Notified Body for product CE mark and support of post-market reporting and MDSAP certification activities.
  • Medical device management and transfer from Medical Device Directive (MDD) to new Medical Device Regulation (MDR) for implementation of regulatory requirements.
  • Product registration at global level, with focus in MDSAP markets (EU, US, CAN, JP, BR) and support to rest of world (ROW) local sites.
  • Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
  • Generate and maintain the DMR/DofC.
  • Attend and support Design review activity and generate environmental checklist, labelling, IFU and ER checklist.
  • Manage ECR/ECO process including notification to S-BCs of changes which are notifiable under regulations

 

 

Other Related Duties:

 

  • Liaise with internal and external specialists and contractors to ensure timely delivery.
  • Liaise with QA/RA management throughout the global organisation to ensure consistent global approach to regulation compliance and Regulatory Intelligence.
  • Ensure current regulations and standards are available.
  • Participate in Continuous Improvement activities
  • Undertake any assignment or duty as required by business needs.
  • Adequacy and regular review of Technical File/Risk Management in accordance with current regulations.
  • Maintenance of SOPs.

 

 

Qualifications & Experience:

 

  • University degree in a scientific subject.
  • 5 to 10 years experience in regulatory affairs medical device or pharma industry at EU level including product registration, technical file compilation and technical compliance.
  • Good understanding of EU MDD/MDR, ISO 13485 requirements
  • Experience in MDSAP markets.
  • Knowledge of active medical devices, risk assessment, clinical experience, post-market surveillance, quality compliance.
  • Systems & Applications (level 2)
  • General & Operational Management expertise (level 1)
  • Departmental/Group Objective & Target Setting (level 1)
  • Training (level 1)
  • Process Validation (level 1)
  • New Product / Change Introduction (NPI & ECR/ECO) (Level 2)

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