Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

Regulatory Affairs Specialist - 100% Remote (UK only) - Outside IR35!

Posted Aug 6, 2021
Job ID: JJJP00007352
Location
Leeds
Duration
11 months, 4 weeks
(Aug 23, 2021 - Aug 23, 2022)
Hours/week
37 hrs/week
Payrate range
50 - 60 £/hr

Regulatory Affairs Specialist - 100% Remote - Outside IR35! 

 

We are looking for 2 Regulatory Affairs specialists (must have a Medical Device or Pharmaceutical experience). 

These roles can be 100% remote (UK based candidates only)

There is a very high chance of extension or permanent role at the end. 


 

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.


 

The Role:

The person will serve as a consultant and technical expert on Regulatory Affairs matters.

Under little to no supervision: provides assistance in preparation and submission of global regulatory documents.


 

Functional and Technical Competencies:

  • Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities
  • Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
  • Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials.
  • Defines data and information needed for regulatory approvals.
  • Develops labelling specifications and approves proposed labelling, packaging, advertising and promotional materials after evaluating conformance to regulations.
  • Provide Regulatory Affairs support during internal and external audits.
  • Plans schedules for regulatory deliverables on a project and monitors project through completion.
  • Assists in the development of best practices for Regulatory Affairs processes.
  • Represents Regulatory Affairs on cross-functional project teams.
  • Partners with other functions to define and obtain data to assist with regulatory submissions.


 

Experience Required:

  • Excellent written, verbal communication and presentation skills
  • Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life- cycle management of products.
  • Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives.  
  • Takes accountability for the achievement of business goals and objectives.
  • Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class II and III devices (EU and USA 510k).
  • Ability to partner and influence key stakeholders on NPD and Lifecycle teams.
  • Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Consider all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear).
  • Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives.
  • Ability to author and submit US, EU and International Regulatory submissions to Regulatory bodies.


 

Leadership Competencies:

  • Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels
  • Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives
  • Lead by leveraging diverse perspectives and backgrounds to generate effective ideas or solutions
  • Deliver by acting with speed, flexibility, accountability  and appropriately managing priorities to deliver results  for  on-time  clearances
     

EDUCATION & EXPERIENCE REQUIREMENTS:

  • BSc or equivalent working experience
  • Practical experience with the preparation and submissions for Class II and III medical devices EU MDD and MDR.
  • Experience of change management determining impact to EU and USA approvals.
  • Substantial experience of EU and International Regulations required.   
  • Knowledge of International Regulations in China, Japan, and Australia preferred.


 

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract with a very high chance of extension or permanent role, chance to work from home 100%& an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 


 

Please Note: This role is OUTSIDE IR35


 

If you are interested in this role please apply now, or for more information contact Tabitha.Crabtree@randstadsourceright.co.uk


Please Note: We are looking for people as soon as possible so please put in your application ASAP or get in touch now! 

Similar jobs

+ View all jobs