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Location: 

Haifa, IL, 3508504

Description: 

Senior Regulatory Affairs Specialist

 


Novocure is a leading medical device company developing a revolutionary treatment for cancer based on the use of electric fields.
 

The Senior Regulatory Affairs Specialist will be part of the Global Regulatory Affairs team, and be responsible for supporting the team in creating and executing regulatory strategies and objectives in alignment with business needs. This includes the preparation of regulatory submissions required to market new or modified medical devices, and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the company’s overall product development process, addresses all regulatory requirements as well as the objectives of the business. Senior Regulatory Affairs Specialist will primarily support the company’s regulatory activities related to new product development, as well as changes in existing commercial products and or in manufacturing processes. The Senior Regulatory Affairs Specialist will also coordinate with the global team to ensure compliance with the processes required by the standards and applicable regulations in US and non-US jurisdictions (Europe, Japan, USA, China and others as needed). This is a full-time position that reports to the Vice President, Global Regulatory Affairs.

 

 

Responsibilities for this position

 

As a Senior Regulatory Affairs Specialist, you will be responsible for new product submissions for regulatory approval, as well as changes to existing approved products, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues, and write regulatory related SOPs.

In this role you will be expected to work independently, meet aggressive timelines, coordinate work of other team members and have close interaction with other groups such as engineering, QA, supply-chain, pre-clinical and clinical development.

 

 

Qualifications:

 

  • MSc (preferably Ph.D) degree in life sciences with 10+ years of experience in regulatory affairs and/or QA within the Medical device /  pharma industry .
  • Substantial experience with regulatory authorities (either in RA or QA capacity)
  • Substantial experience with ISO 13485 implementation
  • At least 5 years of experience in a managerial position - team or project management
  • Proven regulatory experience
  • Knowledge of Medical device regulation
  • Willing to travel 15-20% of the time (Overseas(

 

Skills:

 

  • Ability to effectively manage multiple projects and priorities.
  • Excellent communication skills
  • Ability to work consistently and effectively as part of a team.
  • Attention to details.
  • Using critical thinking, reasoning, problem solving and communication skills
  • Excellent Office software proficiency
  • Excellent English – experience in writing procedures, regulatory documents, lecturer.
  • Ability to work independently; organize, plan and adjust work assignments while meeting deadlines.             

 

 


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