EUDAMED Quality Project Manager

EUDAMED Quality Project Manager

Location: Cork

Working mode: Remote (occasional on-site days in Cork/Dublin)

Duration: 12 months (opportunity for a contract extension)

Hours: 39 hours per week

Pay rate range: Competitive hourly rate (PAYE, Umbrella and Ltd options available)

The EUDAMED Quality Project Manager 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 to ensure that J&J is positioned to support its customers, regulatory requirements, and business needs. The role combines integrating requirements into existing systems and creation of new processes with manging the quality elements of a large project. Additionally, the role will support emerging day-to-day business needs such as managing activity in and related to EUDAME.

roles and responsibilities

Core Responsibilities - Quality and Regulatory Compliance

• Maintenance of EUDAMED program quality plans and reports in a compliant, logical, and efficient manner

• Creation and Management of EUDAMED related GxP training curricula

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

• Supporting and advising documentation changes in relation to EUDAMED when changes such as acquisitions and divestitures occur or product site moves

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

• Assisting teams in the identification and definition of requirements

• Developing potential solutions to deliver requirements and analysis of requirements

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

Core Responsibilities -EUDAMED Support

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

• Managing communication in shared mailboxes within required timelines

• Managing EUDAMED admin

• Assisting the J&J teams working in EUDAMED

how to succeed

Experience, skills & proficiencies desirable:

• Experience working within Quality Management Systems and an understanding of change control is essential.

• Comfortable operating at senior leadership level within the organization and adept at engaging individuals and organizations across multiple levels

• Strong skills in building relationships and partnerships across levels, functions, and sectors to deliver timely and efficient results

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

• Ability to navigate uncertainty in an evolving field and establish the facts needed to develop plans

• Experience in Risk Management Desirable

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

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, LTD & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk (please note that we do not accept applications via email).

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”.