Compliance Specialist - remote

Compliance Specialist  - multicounty (Ireland & UK)

Location: Remote - UK and Ireland

Duration: 12 months

Hours: 39 hours per week

Imagine your next project as a Compliance Specialist, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

The Compliance Specialist is a high-profile role supporting J&J compliance with the EU-MDR requirements in relation to the European Database on Medical Devices (EUDAMED). The successful candidate will work with a high functioning experienced team across all sectors of J&J to ensure that J&J is positioned to support its customers, regulatory requirements, and business needs. 

roles and responsibilities

This will involve: 

• Maintenance of EUDAMED program documents and document structure in a compliant, logical, and efficient manner

• Creation Management of EUDAMED related GxP training curricula affected functions/teams

• Ensuring J&J EUDAMED processes and documents satisfy the requirements of EU-MDR and needs of the business

• Work with Security Analysis team to ensure appropriate control of sensitive data and compliance to EU and J&J procedures

• Supporting and advising documentation changes in relation to EUDAMED when acquisitions and divestitures occur

• Reviewing EUDAMED related changes and ensuring that risks are identified and managed; and that interdependencies between EUDAMED modules are identified and resolved

• Support regression testing following EUDAMED updates

• Supporting and coordinating reporting feedback between J&J and the EU Commission in relation to EUDAMED technical issues

• Co-ordinating Gap Assessments and functional assessments, tracking resulting deliverables within EtQ

• Communicating with leaders at a senior level

how to succeed

You will have the ability to deal with complex issues and will be able to help come up with solutions with your team. You will have very strong communications skills and the ability to build relationships remotely. You will also bring:

• Understanding of EU-MDR (preferably), industry data technology, compliance obligations, the complexity of our various business and quality models

• Experience within a regulatory environment

• Experience within a MedTech industry

• Compliance experience

• Ability to work at a high detail level when required and maintain a wider business perspective

• Experience working on databases or within IT preferably

benefits

This role offers a very competitive hourly rate. This contract will run for a 12 month period. This role offers you the opportunity to grow your knowledge, experience and network in all sectors and functions such as: Supply Chain, Regulatory, Vigilance, Clinical, IT & IT Security

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available (Inside IR35)

questions

If you would like some additional information about the role please contact: simone.strong@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 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”.