Regulatory Affairs Specialist

2 weeks ago

Deeside, Flintshire, United Kingdom ConvaTec Full time
Job Summary

The Regulatory Affairs Specialist will drive improvements in regulatory affairs processes, systems, and infrastructure while supporting regulatory strategy and registration across global markets and the Regulatory Affairs group.

Key Responsibilities
  • Develop and execute regulatory strategies for phased launches of newly developed products, changed devices, and other major projects, collaborating with internal and external stakeholders to meet defined timelines.
  • Generate and approve regulatory technical documentation for various global markets in support of local regulatory and commercial activities.
  • Request support from internal and external stakeholders across multiple processes, including global regulatory activities such as Renewals, Re-registrations, and Change submissions.
  • Support the business in implementing and executing a comprehensive regulatory intelligence system and supporting services.
  • Encourage process improvements and alignment across the Regulatory Affairs group.
  • Maintain regulatory compliance to ensure market approvals.
  • Foster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorship.
  • Provide regulatory support to customer inquiries and authorities.
  • Offer guidance to business partners and junior regulatory staff regarding regulatory requirements, including indications of risk and approximate timing for approval for planning purposes.
  • Review, interpret, and communicate FDA/EU/international regulations and guidance documents to ensure complete and scientifically sound product submissions.
  • Support base business activities, such as Monthly Reports, master data management, portal/listing information, and annual establishment reviews.
  • Identify and support or lead process improvement projects to streamline current activities and increase department efficiencies, including the update, enhancement, creation of new internal policies and procedures, and maintenance of existing procedures.
  • Support regulatory compliance to QSR, ISO, MDSAP, CE, and other worldwide regulatory requirements as appropriate through customer complaints, internal and external audits, and training systems.
  • Regulatory review and approval of documents supporting the QMS and product registrations.
  • Participate as an active member of Industry, Regulatory, or Scientific Committees, as appropriate.
About You
  • A Life Science Degree or equivalent is preferred.
  • RAPS Certification is preferred.
  • Regulatory/Quality experience in medical devices is required.
  • Experience dealing directly with Notified Bodies and global regulatory authorities is required.
  • Preparation and submission of regional technical documentation supporting global registrations across multiple territories globally is required.
  • A continuous improvement mindset with a track record of implementing process improvements for regulatory affairs systems is required.
  • Experience of regulatory requirements for medical devices containing animal-derived materials is preferred.
  • Experience of regulatory requirements for medical devices with an Ancillary medicinal substance is preferred.
  • Knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971, is preferred.
Working Conditions

This position is hybrid with a minimum expectation to travel to the office in Deeside 1-2 days every other week.

There may be rare instances where an employee may be required to work outside of non-core hours/days due to unexpected events, crises, or project timeline pressures.

Convatec provides equal employment opportunities for all current employees and applicants for employment.

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