2 of 2 Permanent Market Surveillance Jobs in the East of England

Regulatory Affairs Manager

Location
Cambridge, England, United Kingdom
design control, verification, validation and change management processes. Lead regulatory activities relating to analytical performance, clinical performance, scientific validity and software validation. Support Post-Market Surveillance (PMS), vigilance, trend reporting and regulatory compliance activities. Conduct regulatory impact assessments and provide guidance on product, manufacturing and quality system changes. … Software, Bioinformatics, Clinical and Quality teams to ensure regulatory requirements are integrated into product development. Support regulatory submissions, Notified Body interactions and market access activities within the EU, UK and other international markets. Provide regulatory training and technical guidance to internal teams and support the Person Responsible for Regulatory ...

Medical Device Quality Specialist Consultant

Hiring Organisation
PA Consulting
Location
Royston, Hertfordshire, United Kingdom
Salary
£ 70 K
based at either our London Victoria or Melbourn (SG8) officeWithin our Life Sciences work, we support global organisations to design, develop and bring to market innovative products that improve patient outcomes. This includes complex combination products across pharmaceuticals, medical devices, biologics and advanced therapies.We are seeking an experienced Medical … medical device quality and regulatory requirements, including product design and development, risk management, and preparation of technical documentation to ensure US/EU market access and compliance.SaMD (Software as a Medical Device): Providing specialised support for Software as a Medical Device, including the implementation and oversight of the software ...