Regulatory Affairs Specialist (M/F)

Jelcz-Laskowice Permanent View Job Description
For our client, an international production company we are currently recruiting candidate for the position of Regulatory Affairs Specialist

Added 27/08/2024

  • great opportunity to join well developed business
  • stable position and high profile organisational culture

About Our Client

Our client is an international company noting a constant growth in its sector in the manufacturing market.

Job Description

  • Provide support and guidance to analyze, design and develop regulatory files on various products and projects.
  • Maintain on-going understanding and knowledge of the latest regulatory requirements in compliance with worldwide regulations and guidance documents. Key focus on European and US regulations.
  • Review, preparation and implementation of regulatory SOPs, in line with both the applicable market requirements and best Group practices.
  • Review regulatory documentation from key resources e.g. customers/projects, products etc. to ensure that customer and company requirements are met.
  • Compilation/support the creation, of regulatory files, for key customers, products and projects.
  • Provide input, at key project/design phases; e.g. pre-sales support, concept/design kick off, project/design review and final project/design transfer to production, to ensure that all regulatory requirements are 'in compliance'.
  • Support validation activities, as necessary, to comply with defined regulatory regulations, global/local procedures and customer requirements.
  • internal and external audits and any associated regulatory/quality assurance programs.
  • Support, co-ordinate/conduct training in Regulatory procedures, as required.
  • Support to the Quality Assurance Department for key operational activities e.g.;
  • non-conformances/complaint reporting, where a regulatory issue is identified;
  • specification approval,
  • remotely support supporting internal and external audits based on approved schedule,
  • update and correction of QMS documents and records archive (related to regulatory).

The Successful Applicant

  • Bachelor's or advanced degree in engineering or a related major scientific discipline
  • Minimum 3 years of experience in regulatory activities and associated requirements
  • Experience within the regulatory industries associated with 21CFR820, ISO 13485, European regulations MDR, EUDAMED
  • Previous experience in FDA and ISO regulated industries
  • Experience in direct communication with Notified Bodies and Regulatory Agencies
  • Ability to work independently or as part of a team to complete projects within required timeframes
  • Highly proficient in spoken and written English

What's on Offer

  • Ability to work in international environment both within internal organizational structure and customers (100% from Western Europe)
  • Dynamic and fast growing culture company
  • Continuous learning environment
  • Opportunity for career progression dependent on achievements
Contact
Sara Bielska
Quote job ref
JN-082024-6517200

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality
Industry
Industrial / Manufacturing
Location
Jelcz-Laskowice
Contract Type
Permanent
Consultant name
Sara Bielska
Job Reference
JN-082024-6517200