Life Cycle management, RA support

Posted 18 November 2021
SalaryNegotiable
LocationZuchwil
Job type Limited
DisciplineScienceLife Sciences
ReferenceBBBH495323_1637234747

Job description

For our client, a leading international pharmaceutical company, we are currently looking for a new team member as a:

Life Cycle management (LCM) RA support

Support the LCM Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance to

  • European Council Directive 92/42/EEC or Regulation 2017/745, as applicable,
  • US FDA 510(k) submissions or Notes to file, as applicable,
  • As well as country registrations on a world-wide basis, as appropriate in the context of Life Cycle Management projects (e.g. change of manufacturing process and/or equipment, change of manufacturing site, etc.).

Key Responsibilities:

  • Ensuring that the company's products comply with the regulations set up by government agencies
  • Advising engineering and other support functions, as well as manufacturing on regulatory requirements
  • Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities
  • Creating, reviewing and maintaining regulatory related technical documentation
  • Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
  • Capturing and verifying regulatory product characteristics to support logistic and supply chain efforts on a global scale
  • Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assisting in review of international product technical documents, marketing and labeling materials
  • Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
  • Providing progress of work-plans and the status of key project deliverables
  • Follow the applicable quality standards and regulatory requirements
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
  • Resolving complex issues as they arise

Qualifications:

  • 5 years of experience in European Medical device industry especially with regulatory, quality or engineering
  • Strong knowledge of: ISO 13485 and ISO 9001, QSR, Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation, MEDDEV guidance documents applicable to Medical Devices products and processes
  • Reasonable knowledge of: FDA requirements, registration requirements in further global markets would be an asset
  • Strong understanding of Risk Management process, label and labeling, change management is desired
  • International experience preferred
  • Proven exceptional written and oral communication skills
  • Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience) Degree in life sciences or engineering is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
  • Familiarity with Technical Documentation structure according to STED required
  • Strong knowledge and skills in MS Office
  • Teamwork oriented, within a multi-functional and multi-national team
  • Strong interpersonal and diplomatic skills
  • Customer / service orientation
  • High analytical, planning and organizational skills; able to set priorities
  • Able to work on multiple simultaneous tasks with limited supervision
  • Quick learner, motivated self-starter
  • Excellent customer service, interpersonal, communication and team collaboration skills
  • Able to cope with internal guidelines change management
  • Some flexibility in working hours is required
  • English spoken and written
  • German would be a plus

Workplace: Zuchwil

Workload: 100%

Start Date: 06.12.2021

Duration: 1 year

Your Application

Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Judith Atgé Martin (+41 61 270 80 16).