Regulatory Affairs Specialist - #1790540

If you need support in completing the application or if you require a different format of this document, please get in touch with at ***************@tcs.com or call TCS London Office number 02031552100 with the subject line: “Application Support Request”. Role: Regulatory Affairs SpecialistJob Type: PermanentLocation: Leeds, UK (Hybrid)Number of hours: 40 hours per week – full time Ready to utilize your experience and expertise in the Regulatory Affairs and Medical Devices? We have an exciting role for you – Regulatory Affairs Specialist.

Careers at TCS: It means more TCS is a purpose-led transformation company, built on belief. We do not just help businesses to transform through technology. We support them in making a meaningful difference to the people and communities they serve - our clients include some of the biggest brands in the UK and worldwide.

For you, it means more to make an impact that matters, through challenging projects which demand ambitious innovation and thought leadership. Build strong relationships with a diverse range of stakeholders. Gain access to endless learning opportunities.

Work closely with the range of teams within the business to bring products to life. The RoleAs a Regulatory Affairs Specialist, you will be providing support to registration activities, CE marking and regulatory submissions as directed by project requirements and worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies. Key responsibilities:Provide support to registration activities, CE marking and regulatory submissions as directed by project requirements.

Demonstrated experience in 510(k), PMA.Experience working with regulatory environments outside of the US and EU.Support worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies. Maintain information on worldwide regulatory requirements and the status of product registrations in data bases such as MDRIM.Keep abreast of developments in worldwide regulatory environments, and to address regulatory requirements as appropriate. Support/Review technical documentation created by teams based remotely and ensure these are complete and accurate.

Effectively translate customer requirement into logical inputs for teams based remotely, including TCS offshore team. Be responsible for adherence to timelines and ensure milestones are achieved. Be responsible for quality of documents prepared and reviewed by self.

Report issues to the Customer and TCS management to ensure appropriate closure. Your Profile Essential skills/knowledge/experience: Experience in Medical Device Regulatory Affairs, preferably in Orthopedics. Knowledge in EU (MDD & MDR), FDA (510k) requirements.

Hands on experience in creating technical files/design dossiers. Proficient with MS Office applications such as MS Word, PowerPoint, Excel. Candidate should possess strong communication and inter-personal skills to deal with Candidate must be flexible to accommodate additional effort needed to meet project and organizational deadlines.

Understanding of registration activities in global markets. Rewards & Benefits TCS is consistently voted a Top Employer in the UK and globally. Our competitive salary packages feature pension, health care, life assurance, laptop, phone, access to extensive training resources and discounts within the larger Tata network.Diversity, Inclusion and Wellbeing Tata Consultancy Services UK&I is committed to meeting the accessibility needs of all individuals in accordance with the UK Equality Act 2010 and the UK Human Rights Act 1998.

We believe in building and sustaining a culture of equity and belonging where everyone can thrive. Our diversity and inclusion motto is ‘Inclusion without Exception’. Our continued commitment to Culture and Diversity is reflected across our workforce implemented through equitable workplace policies and processes.

You’ll find a welcoming culture and many internal volunteering and social networks to join (these are optional). Our diversity, inclusion and social activities include 12 employee networks such as gender diversity, LGBTQIA+ & Allies, mental health, disability & neurodiversity inclusion and many more, as well as health & wellness initiatives and sports events and we sponsor the London Marathon. We welcome and embrace diversity in race, nationality, ethnicity, disability, neurodiversity, gender identity, age, physical ability, gender reassignment, sexual orientation.

We are a disability inclusive employer and encourage disabled people to apply for this role. If you are an applicant who needs any adjustments to the application process or interview, please contact us at ***************@tcs.com with the subject line: “Adjustment Request” or call TCS London Office 02031552100 to request an adjustment. We welcome requests prior to you completing the application and at any stage of the recruitment process.

Next Steps Due to a high volume of applications, we will be unable to contact each applicant individually on the status of their application. If you have not received a direct response within 30 days, then it should be deemed unsuccessful on this occasion. Join us and do more of what matters.

Apply online now.