Regulatory Affairs Project Lead

Regulatory Affairs Project Lead

Location: Cork

Working mode: Remote with occasional site visits to Cork

Duration: 12 months (opportunity for contract extension)

Hours: 39 hours per week

Pay rate range: Competitive hourly rate

Imagine your next project as Regulatory Affairs Project Lead. Your role is to support the day-to-day Regulatory Affairs Supply Chain projects for post approved marketed devices. In addition, this job exhibits a high degree of independent judgment and candidate must execute on plans that directly impact the operational results of business units.

roles and responsibilities

• Works with team members to determine regulatory impact of manufacturing changes on products, prepare and submit applications, and assess the impact product changes have on the status of regulatory licenses.

• Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies. 

• Provides guidance to project team members regarding regulatory compliance issues. 

• Oversees the preparation and maintenance of regulatory submissions and files for both the US and EU Markets

• Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides for assigned projects

• Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of changes to marketed products

• Consults with management personnel to establish and prepare appropriate regulatory filings for product changes

• Independently makes decisions regarding work processes or operational plans and schedules

• Connects by internally collaborating with the Supply Chain, Research and Development, Clinical Affairs, and other partners

• Delivers results for on-time clearances and approvals; change tasks, process improvements for supply chain regulatory matters

how to succeed

• Experience with working with cross functional teams located Globally to coordinate and submit Regulatory impacted Supply Chain Projects is essential

• Previous experience of medical devices and high classification products

• Demonstrated track record of developing and executing global strategies that align with business deliverables is required

benefits

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

you are welcome here

DePuy Synthes 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 DePuy Synthes

DePuy Synthes is the orthopaedic and neurological businesses of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare company. At DePuy Synthes we specialise in our innovations in healthcare products, services and programs that make a real difference to millions of people across the world. We specialise in joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, and also the VELYS™ Digital Surgery portfolio. Contribute to the next healthcare breakthrough with your next project at DePuy Synthes. 

https://www.jnjmedtech.com/en-US/companies/depuy-synthes

https://www.jnjmedtech.com/en-GB/companies/depuy-synthes

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

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”.