Regulatory Affairs Specialist

Regulatory Affairs Specialist

Location: Remote (candidates must be based in the UK)

Duration: 12 months (opportunity for a contract extension)

Hours: 37 hours per week

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

roles and responsibilities

• Responsible for supporting activities that initiate and maintain international product approvals for countries across multiple business units.

• Defines data and information needed for regulatory approvals

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

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

• 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 colleagues at DePuy Synthes companies and the Regulatory Operation team; and to provide support and advice to worldwide company colleagues.

• 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..

• Consults with various countries 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 complex submissions for compliance.

• 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.

Functional and Technical Competencies:

• Excellent written, verbal communication and presentation skills.

• Experience in the preparation and submission of international regulatory filings, including Global Regulations.

• Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.

• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.

• Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions.

• Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.

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 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-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”.