Regulatory Affairs Manager

Personnel Futures Ltd
Southend-On-Sea, UK
24 Aug 2019
01 Sep 2019
Contract Type
Full Time
To ensure the appropriate licensing, marketing and legal compliance of Medical and Industrial manufactured products.

Key Result Areas
  • 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

Principal Responsibilities
  • 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.
  • 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.

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.
  • Participate in Continuous Improvement activities
  • Adequacy and regular review of Technical File/Risk Management in accordance with current regulations.

Qualifications & Experience

University degree in a scientific subject.

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.

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