Regulatory Specialist - Hybrid or Remote - OUTSIDE IR35

Regulatory Specialist - Hybrid or Remote - OUTSIDE IR35

• Ideally, we are looking for candidates commutable to Leeds or Blackpool however we will also consider fully remote candidates for this role (must be UK based).
• A higher rate is available for LTD companies, the advertised rate is PAYE. 
• We are looking for 4 candidates for this role.

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 Project/Role:

• Serves 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, including, but not limited to MDR files.

Duties and Responsibilities:

• 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 labeling, and promotional materials.
• Defines data and information needed for regulatory approvals.
• Develops labeling specifications and approves proposed labeling, 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.

Functional and Technical Competencies:

• 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).
• 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. Considers 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, with a focus on MDR.

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), MDR experience preferred.
• Substantial experience of EU and International Regulations required.   Knowledge of International Regulations in China, Japan, Brazil and Russia is preferred.

In Return:

• Minimum 12-month contract, very high chance of extension
• Different rates available for LTD Company contractor

 & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• This role is OUTSIDE IR35. There are higher LTD Company rate options available - not advertised, advertised rate is PAYE.
• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application. 

If you would like some additional information about the role please contact: Tabitha.crabtree@randstadsourceright.co.uk

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.