Regulatory Affairs Project Manager - Pinewood, Wokingham (Hybrid)

Regulatory Affairs Project Manager - Pinewood, Wokingham (Hybrid)

This is a Hybrid role and you will be required on site 2 -3 days a week. 

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:

The Project Manager for UKCA - UK is a critical position responsible for ensuring the implementation and execution of the Project 2023 program is completed for the regulatory affairs function according to timelines and budget. The Project Manager will assist with providing regulatory strategies and interpretations for the implementation of the new UK legislation across MedTech suppling products to the UK, support with tracking of resource allocations and submissions to UK CABs according to the budget & ownership and deployment of franchise shared procedures to support the QMS requirements of the UKCA.

With expertise in Regulatory Affairs, this role will proactively coordinate the regulatory strategy deliverables for MedTech UK/IRE and liaise with the relevant stakeholders to allow the overall successful delivery of compliant Technical Documentation and UKCA Marking.

Duties and Responsibilities:

• Utilizing the expertise within the Regulatory organization, develops and co-ordinates execution of the strategies for the program to align with expectations.
• Drives consistency across all platforms across Medical Devices for technical documentation creation and adherence to procedures.
• Develops and maintains constructive and cooperative working relationships with business functions in the organization.
• Establishes and leads regulatory objectives to identify and deliver all required regulatory project activities. 
• Supports the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule and resource model.
• Working across the businesses and franchises, develops solutions and aligns on regulatory strategies with an emphasis on an ability to work with SMEs in labelling, quality and regulatory compliance.
• Supports the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges and process improvements throughout the program.
• Identifies and facilitates continuous improvement activities.
• Provides clear and timely communication of new and changing requirements to the Franchise regulatory teams.
• Educates franchise Associates on UK regulations and requirements and integrating those requirements into franchise shared procedures.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.
• Reports: May include contractor resource, as required

Experience Required:

• Bachelor’s degree with 5-8 years of experience or PhD, Pharm, Masters, legal degree with adequate experience required. Advanced degrees and education in medicine, engineering, science or law preferred. 
• Adequate experience in EU regulatory requirements for medical devices required.
• Experience of managing Projects with team members in several different locations, acted as a PMO
• Travel: Up to 10% travel may be required

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 18 month contract & 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 INSIDE IR35. The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
• We are looking to process the first round of applications within the next 2 working days.
• 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. 

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 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”.