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- Tasks: Support regulatory submissions and CE marking for medical devices.
- Company: Join TCS, a purpose-led transformation company making a meaningful impact globally.
- Benefits: Enjoy competitive salary, health care, training resources, and discounts within the Tata network.
- Why this job: Be part of innovative projects and build relationships with diverse stakeholders in a welcoming culture.
- Qualifications: Experience in Medical Device Regulatory Affairs and knowledge of EU and FDA requirements are essential.
- Other info: Flexible working options available; we embrace diversity and encourage all to apply.
The predicted salary is between 28800 - 48000 £ per year.
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.
The Role: As 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 databases 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 requirements 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.
- 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.
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 with the subject line: “Adjustment Request” or call TCS London Office 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.
Regulatory Affairs Specialist employer: Tata Consultancy Services
Contact Detail:
Tata Consultancy Services Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines in the medical device sector, especially those related to CE marking and FDA submissions. This knowledge will not only boost your confidence but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals already working in regulatory affairs, particularly those in the medical devices industry. Attend relevant conferences or webinars to connect with potential colleagues and learn about their experiences, which can provide valuable insights into the role.
✨Tip Number 3
Prepare to discuss specific examples of your experience with 510(k) and PMA submissions during interviews. Highlight any successful projects where you contributed to regulatory compliance, as this will showcase your practical knowledge and problem-solving skills.
✨Tip Number 4
Demonstrate your ability to work collaboratively with diverse teams by sharing examples of past experiences. Emphasise your communication skills and flexibility, as these are crucial for effectively translating customer requirements and meeting project deadlines.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Affairs Specialist position. Tailor your application to highlight relevant experience in medical device regulatory affairs, particularly in orthopaedics.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with CE marking, 510(k), and PMA submissions. Provide specific examples of how you've successfully navigated regulatory environments and compiled technical documentation.
Showcase Communication Skills: Since the role involves building relationships with diverse stakeholders, demonstrate your strong communication and interpersonal skills. Include examples of how you've effectively collaborated with teams, especially in remote settings.
Proofread Your Application: Ensure that your CV and cover letter are free from errors and clearly formatted. A well-presented application reflects your attention to detail, which is crucial in regulatory affairs. Consider asking a friend or colleague to review your documents before submission.
How to prepare for a job interview at Tata Consultancy Services
✨Know Your Regulatory Frameworks
Familiarise yourself with the key regulatory frameworks relevant to the role, such as EU MDD & MDR and FDA 510(k) requirements. Being able to discuss these in detail will demonstrate your expertise and readiness for the position.
✨Prepare for Technical Questions
Expect questions about your experience with technical files and design dossiers. Be ready to provide specific examples of your past work and how it relates to the responsibilities of a Regulatory Affairs Specialist.
✨Showcase Your Communication Skills
Since the role involves liaising with various stakeholders, highlight your strong communication and interpersonal skills. Prepare examples of how you've effectively communicated complex regulatory information in previous roles.
✨Demonstrate Flexibility and Problem-Solving
The job requires flexibility to meet project deadlines. Be prepared to discuss situations where you had to adapt quickly or solve unexpected problems, showcasing your ability to thrive in a dynamic environment.
