EUDAMED Project Lead

Location: Remote 

Duration: 12 months

Hours: 40 hours. Flexibility may be required due to different timezones

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

roles and responsibilities

The EUDAMED Project Lead is responsible for leading and directing cross-functional implementation and execution activities within the CSS Franchise to prepare the business for EUDAMED readiness in advance of mandatory usage. This includes managing the CSS project plan, driving cross-functional readiness activities and aligning with stakeholders across CSS, enterprise and equivalent partners in Ethicon and DPS to collaborate and align on the MedTech solution and approach. This will involve: 

• Drives decision-making and stakeholder alignment at a team, Business Unit, franchise, and functional level 

• Develops, manages and maintains project plan for Eudamed implementation activities for CSS franchise

• Interprets requirements and translates into executable actions for the functions and business

• Ensures integration of EUDAMED requirements, including change management, into franchise procedures and processes

• Acts as a change agent, ensuring the changes that come with EUDAMED are understood by all functions impacted; educates franchise Associates and Leadership on EUDAMED requirements

• Provides direction to a diverse contractor team and various matrixed CSS Working Groups

• Escalates risks and issues and provides solutions

• Partners with J&J to ensure CSS representation in various internal and external forums, including collaboration with Policy and outreach to influence the EUDAMED system requirements

• Leads Franchise Eudamed Forums

• Shares best practice and knowledge with equivalent E2E Leads

• Participates in UDI workshops representing CSS

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

how to succeed

You will also bring:

• Advance degree or equivalent degree required (PhD, Masters or equivalent degree with adequate experience).

• 8-10 years of experience required.  

• Experience in EU regulatory requirements for medical devices required

• Proven project management experience

• Knowledge in the requirements for EUDAMED

• Experience in EU regulatory requirements for medical devices required

• Ability to partner and Influence key stakeholders

• Results-orientation and sense of urgency

• Excellent written and verbal communications skills in English

• Knowledge and thorough understanding of how regulations impact product registration and market access

• Ability to work effectively in a highly matrixed organization

details

• This role offers a very competitive hourly rate. 

• This contract will run for a 12 month period and has a strong chance of extension. 

• Remote working. This role will require some flexibility due to timezone differences. You may be required to join meetings between the hours of 5pm - 8pm. 

• 10 - 15% travel required including to EU (Belgium) and USA (California, New Jersey).

you are welcome here

J&J 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 MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

https://www.jnj.com/healthcare-products/medtech

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. 

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”.