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Aktualne oferty pracodawcy

R&D Manager, Product Documentation

Radiometer Solutions Sp. z o.o.About the company

  • Stargard

    Stargard, West Pomeranian
  • Offer expired a month ago
  • Remote recruitment
  • contract of employment
  • full-time
  • manager / supervisor

Your responsibilities

  • We are looking forward to get in touch with you if you have an experience with team management and product documentation – most likely from Research & Development (R&D) or Regulatory Affairs / Quality Assurance (RA/QA) within the Medical Devices or other highly regulated industry. You will join a team of highly skilled colleagues in R&D Product Lifecycle Management (PLM) group. The PLM team takes care of products presence on the market, such as redesign to handle end of life components, adaptation to new regulations, new standards and addressing quality & customer problems.

  • Team management with planning, prioritization and coordination activities.

  • Taking care of the team, their development and atmosphere of daily work.

  • Setting the documentation standards for launched products together with colleagues from R&D team in Poland and Denmark.

  • Coordinating projects and tasks in an international environment.

  • Continuously improving product documentation to allow us staying in compliance,

  • Staying up to date with and having an in depth understanding of requirements in regulations/standards (21CFR820.30, ISO13485, ISO14971, IEC62366, IEC62304 and the new EU IVD/MD regulation)

  • Taking full responsibility for defined documentation activities within launched Radiometer products.

Our requirements

  • A Master or Bachelor degree in Engineering, Pharmacy, or similar, combined with experience within medical device or other highly regulated industry.

  • 3+ years of experience in team management.

  • Proven experience in technical documentation (especially within Risk Management and Requirements Engineering).

  • Experiences in Medical Devices (MD) or In Vitro Diagnostic Devices (IVD) industry, with focus on requirements/design, is a benefit.

  • Knowledge of Medical Industry regulations is a benefit (MDR/IVDR, ISO13485, ISO14971, CFR Part21 and FDA guidelines on Design Control).

  • Experience with cross-functional and cross-cultural project execution.

  • Fluent English and Polish required in written and oral.

  • Very good communication skills used to team management and to have a cross-functional interaction.

  • Self-driven person with focus on achieving goals.

  • Able to coordinate tasks and handle stakeholders with pragmatism and common sense.

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • life insurance

  • remote work opportunities

  • flexible working time

  • fruits

  • integration events

  • coffee / tea

  • drinks

  • parking space for employees

  • leisure zone

  • extra social benefits

  • meal passes

  • holiday funds

  • christmas gifts

  • employee referral program

  • charity initiatives

  • family picnics

  • Opportunity to grow in a company with a strong LEAN culture

  • Employee Assistance Program