Regulatory Affairs
5 months ago
**Now’s our time to inspire the future of healthcare together.** Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Do you have regulatory experience, and are you seeking a new job? Siemens Healthineers is looking for a full-time Regulatory Affairs Specialist, and the remote role comes with an attractive salary and benefits package.
As a Regulatory Affairs Specialist, you will provide regulatory support to the European Authorised Representative (EU AR) team on a day to day basis. This role reports to and supports the EU Authorised Representative Manager to ensure compliance to the requirements of IVDR Regulation (EU) 2017/746, UK regulation (MDR 2002), as well as other relevant global regulatory framework. This team works closely with other departments providing regulatory/ quality support in a manner that is consistent with the company's Business Principles.
In this role, you can expect to:
- Be responsible for day to day EU AR Team input into complaint handling tool
- In relation to Manufacturer Incident Reporting (MIR) in UK & EU countries, liaise with legal Manufacturers and country Quality Teams, provide reporting recommendation, review and approve reports, ensure on time processing and filing with National Competent Authorities
- Co-ordinate the EU AR Team MIR enquiries
- Be a Point of Contact for EU AR / UK Responsible Person on behalf of the US & UK legal Manufacturers
You will also require the following:
- Degree qualification in a relevant discipline (Regulatory Affairs or Quality degree is desirable but not mandatory) and/or appropriate professional experience gained working in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
- Proficient in Microsoft Office (including Outlook, Excel, Word, SharePoint, etc)
- Promote excellence and embrace right first time culture. A strong understanding of the need for accuracy
- Work efficiently and be self-disciplined
- To work well under pressure and to be able to identify the need to prioritise when required
- To be a dynamic team player who displays problem solving skills, who can work effectively and proactively on activities both individually and within a team
- Good communicator fluent in English in both speaking and writing with strong organisational skills
-
Regulatory Affairs Officer
1 month ago
Birmingham, United Kingdom CV-Library Full timeEvolve are working with a leading pharmaceutical organisation who have been a key player in procuring and supplying pharmaceutical products in the UK. They maintain strong relationships with leading pharmacy groups, manufacturers and the NHS to provide a wide range of products at competitive prices in the market. They’re on the search for a motivated...
-
Regulatory Affairs Specialist
4 weeks ago
Birmingham, Birmingham, United Kingdom Evolve Selection Ltd Full timeRegulatory Affairs Officer **About the Role** Evolve Selection Ltd is working with a leading pharmaceutical organisation to find a motivated Regulatory Affairs Officer to join their team based in the West Midlands. **What's on Offer?** * Highly competitive salary * Flexible hours after 6 months * Onsite training **Ideal Requirements** * At least 6...
-
Regulatory Affairs Specialist
4 weeks ago
Birmingham, Birmingham, United Kingdom Evolve Selection Ltd Full timeRegulatory Affairs Officer **About the Role** Evolve Selection Ltd is working with a leading pharmaceutical organisation to find a motivated Regulatory Affairs Officer to join their team based in the West Midlands. **What's on Offer?** * Highly competitive salary * Flexible hours after 6 months * Onsite training **Ideal Requirements** * At least 6...
-
Regulatory Affairs Specialist
1 month ago
Birmingham, Birmingham, United Kingdom Evolve Selection Ltd Full timeRegulatory Affairs Officer OpportunityEvolving pharmaceutical solutions require a skilled Regulatory Affairs Officer to ensure compliance and quality. We're seeking a motivated professional to join our team in the West Midlands.This is a full-time permanent position offering a competitive salary, flexible hours, and onsite training.Key...
-
Regulatory Affairs Specialist
1 month ago
Birmingham, Birmingham, United Kingdom Evolve Selection Ltd Full timeRegulatory Affairs Officer OpportunityEvolving pharmaceutical solutions require a skilled Regulatory Affairs Officer to ensure compliance and quality. We're seeking a motivated professional to join our team in the West Midlands.This is a full-time permanent position offering a competitive salary, flexible hours, and onsite training.Key...
-
Regulatory Affairs Specialist
4 days ago
Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full timeThe Global Regulatory Affairs team at Thermo Fisher Scientific seeks a Regulatory Affairs Specialist to support the registration of products in global markets. The successful candidate will be responsible for interpreting local regulatory requirements, preparing submission documentation and tracking registrations to completion.Key responsibilities...
-
Chemical Regulatory Affairs Specialist
4 weeks ago
Birmingham, Birmingham, United Kingdom Ramboll Group AS Full timeSenior Regulatory Affairs ConsultantWe are seeking a highly skilled and experienced Senior Regulatory Affairs Consultant to join our Health Sciences department at Ramboll Group A/S. As a key member of our team, you will play a crucial role in supporting organisations around the world in bringing products to market that meet relevant regulatory requirements...
-
Chemical Regulatory Affairs Specialist
4 weeks ago
Birmingham, Birmingham, United Kingdom Ramboll Group AS Full timeSenior Regulatory Affairs ConsultantWe are seeking a highly skilled and experienced Senior Regulatory Affairs Consultant to join our Health Sciences department at Ramboll Group A/S. As a key member of our team, you will play a crucial role in supporting organisations around the world in bringing products to market that meet relevant regulatory requirements...
-
Regulatory Affairs Expert
2 weeks ago
Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full timeThe Global Regulatory Affairs team at Thermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist II to join their team. The successful candidate will be responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac.A Day in the Life:Prepare and submit registration documentation to ensure...
-
Regulatory Affairs Officer
3 weeks ago
Birmingham, United Kingdom Evolve Selection Full timeEvolve are working with a leading pharmaceutical organisation who have been a key player in procuring and supplying pharmaceutical products in the UK. They maintain strong relationships with leading pharmacy groups, manufacturers and the NHS to provide a wide range of products at competitive prices in the market. They’re on the search for a motivated...
-
Birmingham, Birmingham, United Kingdom Michael Page (UK) Full timeJob Title: Quality Assurance and Regulatory Affairs ManagerJob Summary:We are seeking a highly experienced Quality Assurance and Regulatory Affairs Manager to join our team at Michael Page (UK). As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance across our global operations.Key...
-
Regulatory Affairs Specialist II
2 months ago
Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full timeJob Title: Regulatory Affairs Specialist IIThe Regulatory Affairs Specialist II plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...
-
Regulatory Affairs Specialist II
2 months ago
Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full timeJob Title: Regulatory Affairs Specialist IIThe Regulatory Affairs Specialist II plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...
-
Regulatory Affairs Specialist
3 weeks ago
Birmingham, Birmingham, United Kingdom Athsai Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Athsai. The successful candidate will be responsible for developing and implementing global regulatory strategies to support the development of biomarkers, companion diagnostic tests, and digital health devices.Key ResponsibilitiesDevelop and implement global...
-
Regulatory Affairs Specialist
2 weeks ago
Birmingham, Birmingham, United Kingdom Hays DT - Midlands Full timeHays DT - Midlands is seeking a skilled Regulatory Affairs Support Officer to ensure the accuracy and compliance of financial claims, funding delivery, and associated participant paperwork within our Employment & Skills Programmes.Key Responsibilities:Verify financial claims for accuracy and compliance with funding guidelines, ensuring seamless delivery of...
-
Birmingham, Birmingham, United Kingdom Michael Page (UK) Full timeJob Title: Quality Assurance and Regulatory Affairs ManagerAs a key member of our team, you will play a crucial role in ensuring the highest standards of quality and regulatory compliance across our global operations.Key Responsibilities:Quality Assurance: Develop and implement quality management systems to ensure products meet customer requirements and...
-
Birmingham, Birmingham, United Kingdom Michael Page (UK) Full timeJob Title: Quality Assurance and Regulatory Affairs ManagerAs a key member of our team, you will play a crucial role in ensuring the highest standards of quality and regulatory compliance across our global operations.Key Responsibilities:Quality Assurance: Develop and implement quality management systems to ensure products meet customer requirements and...
-
Birmingham, Birmingham, United Kingdom Michael Page UK Full timeGlobal Quality Assurance ManagerAs a key member of our team, you will play a pivotal role in driving our quality improvement strategy forward. Working closely with senior management, suppliers, and customers, you will foster a culture of excellence and best practices.Key Responsibilities:Ensure all products meet the highest standards of quality, safety, and...
-
Regulatory Affairs Specialist Ii
5 months ago
Birmingham, United Kingdom Thermo Fisher Scientific Full time**At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...
-
Regulatory Affairs Specialist II
1 week ago
Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full timeThe Regulatory Affairs Specialist at Thermo Fisher Scientific plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets. This includes interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to completion.A Day in the Life:Author, compile, and submit...