Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Join us as a QA/RA Specialist, ensuring compliance and managing quality systems in the pharma and medical device sectors.
- Company: Be part of an innovative market leader in the dental industry with a global presence.
- Benefits: Enjoy 26 days of annual leave, flexible benefits, and access to LinkedIn Learning for your growth.
- Why this job: This role offers hands-on experience in regulatory compliance and project management in a dynamic environment.
- Qualifications: A degree in science, engineering, or medical discipline is preferred; some experience in regulated environments is a plus.
- Other info: You'll have opportunities for personal and professional development through mentoring and coaching programs.
The predicted salary is between 36000 - 60000 £ per year.
QARA Specialist
Reporting to the EMEA QA/RA Manager, in this role your main functions will be to maintain and develop the local quality and pharmacovigilance management system, support the product registration with local competent authorities, undertake relevant training to deputise for Responsible Person (RP) and manage various projects.
Role responsibilities
- Responsible for the regulatory compliance of the site according to UK and Ireland regulations for Pharma and Medical Device distribution
- Preparation and/or coordination of data and analytics for the monthly Product Surveillance Committee
- Documentation review for the batch release of Pharmaceutical manufactured products
- Supporting the supply of regulatory information to international divisions and external parties
- Preparation and presentation of pharmacovigilance reports
- Maintain an effective ISO 13485 certified Quality Management System (QMS) that enhances the customer facing value of the organisation and reduces business risk, ensuring that processes needed for the QMS are documented.
- Execution of audits of dealers against the annual audit plan, management of CAPAs and escalation of any critical deficiencies as deemed necessary
- Maintain good documentation practice and manage the UKD Document Control infrastructure (including, but not limited to activities associated with CAPAs, Change Controls, Nonconformance)
- Maintain knowledge of any changes in Medical Device and Pharmaceutical regulations and the potential impact on the UKD manufacturing and distributing activities. Examples include EU MDR, MDD, Brexit, GxP, environmental requirements
- Communicate with clarity and succinctness the nature of the change, impact on the business, and options that can be considered to remediate and/ or mitigate the impact of any potential change
- Support product registrations with local competent authorities
- Support Health Authority/ Notified Body inspections on investigational sites or external service providers. Also support with the drafting of any responses and execution of any post inspection activity
- Conduct any other QARA related activities in line with the Quality Plan as defined by the EMEA QARA Manager
- Escalate urgent and critical matters to EMEA QARA Manager where necessary.
Profile requested
- Educated to Degree level, preferable in a science, engineering or medical discipline desirable
- Some experience within highly regulated environment (e.g. ISO 13485, GDMP)
- Preferable internal audit experience
- Strong customer service and interpersonal skills
- High degree of accuracy and attention to detail
- Project management desirable
As part of our team, you\’ll experience the spirit of an international and innovative market leader in the dental industry. Besides an attractive remuneration package, you will also be eligible for a variety of employee benefits, such as:
26 days\’ annual leave, an attractive company pension scheme and a flexible benefit scheme ( including health insurance, dental cover, medical cash plan…).
We attach great importance to your development: a comprehensive induction, further training opportunities and access to LinkedIn Learning are available to you. Take advantage of personal and professional development opportunities through our worldwide mentoring and coaching program. In addition, we offer an extensive, global employee assistance program that provides a wide range of benefits as well as retirement benefits.
QA/RA Specialist employer: Dentsply Sirona
Contact Detail:
Dentsply Sirona Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA/RA Specialist
✨Tip Number 1
Familiarize yourself with the latest UK and Ireland regulations for Pharma and Medical Device distribution. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance and quality management.
✨Tip Number 2
Network with professionals in the QA/RA field, especially those who have experience with ISO 13485 and GDMP. Engaging with industry experts can provide valuable insights and potentially lead to referrals or recommendations.
✨Tip Number 3
Stay updated on recent changes in Medical Device and Pharmaceutical regulations, such as EU MDR and Brexit. Being knowledgeable about these changes will set you apart as a candidate who is proactive and informed.
✨Tip Number 4
Prepare to discuss your project management skills and any relevant experiences during the interview. Highlighting your ability to manage projects effectively will show that you can handle the responsibilities of the role.
We think you need these skills to ace QA/RA Specialist
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the QA/RA Specialist position. Understand the key responsibilities and required qualifications, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize any experience you have in highly regulated environments, particularly with ISO 13485 or GDMP. Mention specific projects or roles where you demonstrated strong attention to detail and project management skills.
Showcase Your Skills: Clearly outline your customer service and interpersonal skills in your application. Provide examples of how you've successfully communicated complex information in previous roles, as this is crucial for the position.
Tailor Your Documents: Customize your CV and cover letter to reflect the language and requirements mentioned in the job description. Use keywords from the listing to ensure your application stands out to hiring managers.
How to prepare for a job interview at Dentsply Sirona
✨Understand Regulatory Compliance
Make sure you have a solid grasp of UK and Ireland regulations related to Pharma and Medical Device distribution. Be prepared to discuss how your previous experience aligns with these regulations and how you can ensure compliance in this role.
✨Showcase Your Attention to Detail
Given the importance of accuracy in QA/RA roles, be ready to provide examples from your past work where your attention to detail made a significant impact. This could include experiences with documentation review or managing CAPAs.
✨Prepare for Project Management Questions
Since project management is desirable for this position, think of specific projects you've managed or contributed to. Be ready to discuss your approach to managing timelines, resources, and stakeholder communication.
✨Communicate Clearly and Succinctly
Effective communication is key in this role, especially when discussing changes in regulations or impacts on the business. Practice articulating complex information in a clear and concise manner, as this will demonstrate your ability to communicate effectively with various stakeholders.
