Regulatory Affairs Manager

Recruiter
Personnel Futures Ltd
Location
Southend-On-Sea, UK
Salary
Competitive
Posted
24 Aug 2019
Closes
01 Sep 2019
Ref
1239963869
Sector
Engineering
Contract Type
Permanent
Hours
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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