Regulatory Affairs Project Lead

Regulatory Affairs Project Lead

Location: Leeds (Beeston)

Working mode: Hybrid, 3 days on-site and 2 WFH

Duration: 2 years (opportunity for a contract extension)

Hours: 37 hours per week

Pay rate range: Approx. £40/per hour (PAYE and Umbrella options available)

Imagine your next project Regulatory Affairs Project Lead at DePuy Synthes (part of J&J family of companies). The successful candidate will be responsible for production of documents and files such as standard regulatory submissions, annual reports, general correspondence, adverse event reports and promotional materials for submission to various regulatory agencies. These positions act as team leads and are accountable for the success of projects and may be the primary contact for strategy leads and LOC’s.  Individuals in these positions frequently have significant amounts of critical organizational knowledge.  Positions at this level are considered subject matter experts.

roles and responsibilities

Responsible for supporting activities that initiate and maintain international product approvals for countries across multiple business units. This will involve: 

• Defines data and information needed for regulatory approvals

• Coordinate and project manage global registrations in accordance with countries focus, country registration plans and commercial launch targets. 

• Provides Regulatory support to  Supply Chain and QA PMI regarding any issues to ensure no gap in supply.

• Ensure all quality and compliance issues related to registrations are supported in line with responsibilities and Global G&O’s. 

• To effectively manage regulatory activities to ensure the Department supports business objectives.

• To ensure product approval and registration is obtained for all new products by ensuring that new product dossiers are created where appropriate in line with local country requirements.

• To drive effective registration strategies to ensure regulatory projects are standardized to obtain earliest possible approval.

• To establish and maintain processes for the status and maintenance of registrations, interim notifications and periodic re-submissions.

• Partners with Regulatory colleagues in developing strategies ensuring clear visibility to risks and early identification of regulatory challenges.

• To establish and maintain good relationships with Regulatory Authorities, Regulatory colleagues at DePuy Synthes companies and distributors; and to provide support and advice to worldwide company colleagues.

• To liaise as appropriate with all internal departments to provide regulatory direction, input and support.

• To represent the Regulatory Department to external Regulatory Bodies and customers.

• To maintain progress and developments of worldwide regulatory environments, and to address regulatory requirements as appropriate.

• To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results and adhered to in a fair and consistent manner within the Regulatory Department.

• Prepares and submits complex submissions to regulatory agencies. 

• Reviews and submits information on compliance activities and related documentation as required to receive agency approvals or in response to agency requests. 

• Consults with various departments regarding submission requirements and standards to facilitate efficient processing by agencies. 

• Ensures that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. 

• Reviews documents prepared by less experienced staff to ensure all agency and quality standards are met. Interprets and enforces paper and electronic regulatory submission standards, policies and operating procedure requirements. 

• Reviews complex submissions for compliance. 

• Maintains an ongoing positive working relationship with publishing contributors. 

• Uses contacts to obtain relevant information for submissions and expedite the submission process.

how to succeed

• A good first degree in a relevant discipline, or equivalent.

• Significant regulatory experience covering medical devices.

• Commanding knowledge of worldwide regulatory procedures, especially for medical devices.

• Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements

• Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.

• Relevant experience gained in supervising Regulatory staff to ensure effective contribution and coordination.

• Possess computer competency in Microsoft office software, data collection and general analysis tools.

leadership competencies:

• Connect  by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels

• Shape policy and external focus by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives

• Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions

• Deliver by acting with speed, flexibility , accountability  and appropriately managing  priorities to deliver results  for  on-time  clearances

• Strategic thinking and big picture orientation

• Collaboration and Teaming

• Global mindset

• Talent and organisational development

benefits

This role offers a very competitive hourly rate. This contract will run for 2 years 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 & 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”.