Regulatory Affairs Specialist

Regulatory Affairs – Strategic Support

Location: Leeds, Blackpool or Remote

Duration: End of year initially with possibility of extension

Hours: 37 per week

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

roles and responsibilities

To provide regulatory affairs support, direction and execution expertise to the relevant strategic projects as identified by functional management.  Responsibilities are to cover DePuy Synthes businesses but with a focus on devices which are considered purchase for resale. This will involve: 

• Responsible for directing submissions to regulatory authorities to support product registration and lifecycle management, including coordinating, reviewing, and preparing submission deliverables.

• Provides strategic direction to teams on interaction and negotiation with government regulatory agencies to expedite approvals. 

• Evaluates new regulations and standards for impact to existing ways of working to ensure development of high-quality deliverables. 

• Acts as a regulatory subject matter representative on the project team(s) throughout the product lifecycle. 

• Provides regulatory advice to development and/or marketing teams on appropriate regulations and interpretations. 

• Coordinates and maintains reporting schedules for all medical devices and marketed products notices as required.

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

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• For those who supervise or manage a staff, responsible for ensuring that 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, if applicable

• 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

• 2-4 years experience in a relevant regulatory affairs role and a bachelor’s degree in a scientific discipline is preferred

• Experience in the Medical Device industry or medical field

• Demonstrated knowledge of manufacturing principles and practices, and procedures

• Knowledge of specific business practices and software and software applications

• Able to enter data on spread sheet and database applications

• Ability to communicate effectively with a diverse clientele base

• Ability to work cooperatively with coworkers

• Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements

benefits

This role offers a very competitive hourly rate. This contract will run until the year of the year and has a strong chance of extension. 

you are welcome here

DePuy 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 and Umbrella options are available. 

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”.