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Regulatory Affairs Executive
5 days ago
Takeda Pharmaceutical London, United Kingdom**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. · Within our Regulatory ...
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Regulatory Affairs Consultant
1 week ago
Blackfield Associates Greater London, United KingdomMy client, a Bio-therapeutic business based in Greater London, has defined the duties as: · - Preparation of reg affairs for MHRA inspection · - Support for ROW/EU to allow full time members of team to focus on regulatory strategy and regulatory inspection preparation. · - Part o ...
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Regulatory Affairs Executive
5 days ago
ARIAD London, United KingdomThe Europe & Canada (EUCAN) Business unit supports Takeda's mission at a regional level and as the leader in rare diseases and specialty care, we champion better health and a brighter future for patients, healthcare providers and our people. · Across the EUCAN BU, patients come f ...
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Regulatory Affairs Specialist
22 hours ago
ConvaTec London, United KingdomPioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infu ...
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Regulatory Affairs Associate
5 days ago
WEP Clinical London, United KingdomJob Title: Regulatory Affairs Associate · Company: WEP Clinical · Location: Hybrid/Onsite - Chiswick Tower, London, England · Are you passionate about regulatory affairs and looking for an opportunity to positively impact patients' lives globally? Are you interested in supporting ...
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Regulatory Affairs Change
1 week ago
eFinancialCareers London, United Kingdom**Regulatory Affairs Change · £120,000 - £135,000 + Bonus + Benefits · London** · Growing London banking group, part of one of the world's largest banks by assets, has a new Central Compliance role within their Legal & Compliance area in the corporate banking and capital markets ...
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Emea Regulatory Affairs
5 days ago
JPMorgan Chase Bank, N.A. London, United Kingdom**Posting description** · You are a strategic thinker with strong time management skills, passionate about working across a range of complex issues. You have found the right team. · You will be a regulatory policy specialist who will contribute to a range of advocacy efforts on p ...
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Regulatory Affairs Specialist
22 hours ago
AstraZeneca London, United Kingdom**Regulatory Affairs Specialist** · **Location: Pancras Square** · **Competitive Salary & Benefits** · **Advert Closing Date: 24/02/23** · AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisa ...
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Regulatory Affairs Professional
1 week ago
BT London, United KingdomRegulatory Affairs Professional · **Job Req ID**:30548**Posting Date**:5 Mar 2024**Function**:Corporate and Regulatory Affairs**Unit**:Legal, CoSec & Regulatory Affairs**Location**:1 Braham Street, London, United Kingdom**Salary**:Competitive Salary & Great Benefits**Why BT Group ...
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Regulatory Affairs Lead
1 week ago
Spark Therapeutics London, United KingdomJoin the Spark Team · We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. · We don't follow foo ...
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Regulatory Affairs Specialist
1 week ago
Alimentiv London, United Kingdom**Unit Management**: · - Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites. · - Conduct or assist with regulatory and/or safety reviews, c ...
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Regulatory Affairs Manager
1 week ago
STR Group Limited London, United Kingdom**Regulatory Affairs Manager - UK Steel** · **Permanent** · **Hybrid working - London based (SW1H). Travel Required** · **Full time** · **Competitive salaries and excellent benefits including matched pension contributions up to 8%** · **UK Steel | Make UK** · **The Manufacturers' ...
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Regulatory Affairs Consultant
6 days ago
Puraffinity London, United Kingdom**Rate**: £500-£600 per day · **Duration of contract**: 3 months with ad hoc work thereafter · **Location**: London with regular office visits · **About the company** · Puraffinity Ltd is a rapidly growing start-up company. We are driven and strive to solve the global problem of ...
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Senior Regulatory Affairs Manager
6 days ago
CK GROUP London, United KingdomCK Group are recruiting for a Senior Regulatory Affairs Manager to join a highly successful pharmaceutical company with a strong portfolio of marketed and developmental products. This is an exciting time for the company as they move to later phase developmentand marketing authori ...
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Regulatory Affairs Manager Esg
1 week ago
Page Group London, United KingdomRegulatory Affairs Manager (ESG & Market Infrastructure) · **Client Details** · Global financial services membership body. · **Description** · I am currently recruiting for a Regulatory Affairs Manager (ESG & Markets Infrastructure) with a global financial services membership bod ...
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Regulatory Affairs Support Officer
6 days ago
eFinancialCareers London, United KingdomJoin us as a Regulatory Affairs Support Officer · - We'll look to you to be a key member of our Risk team and be responsible for upstream regulatory risk management · - You'll be independently and collectively engaging in active horizon scanning of new regulatory risks, as well a ...
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Senior Specialist Regulatory Affairs
1 week ago
MSD London, United KingdomWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succee ...
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Cmc Regulatory Affairs Consultant
3 days ago
G&L Healthcare London, United KingdomWe are an industry-leading independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions. · As demand for our services and solutions continues to grow we are lo ...
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Eu Regulatory Affairs Lead
5 days ago
Spark Therapeutics London, United KingdomJoin the Spark Team · We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treat ...
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Head of Renewables Regulatory Affairs Europe
3 days ago
RWE Offshore Wind London, United Kingdom**Head of Renewables Regulatory Affairs Europe & APAC (d/f/m)**: · - **Location(s)**: · - London, City of London, GB, EC2R 8HP · - Copenhagen, 84, DK, 1620 · - Hamburg, HH, DE, 20354 · - Essen, NW, DE, 45141 · **RWE Offshore Wind GmbH** · **To start as soon as possible, **full ti ...
Regulatory Affairs - London, United Kingdom - Tec Partners
Description
TEC Partners is pleased to have partnered with a pioneering medical device company who is set to pave the way for AI-based automated analysis software to overcome a global crisis affecting millions of lives.
Quality and Regulatory SpecialistAs the Quality and Regulatory Specialist, you will play a pivotal role in my client's mission to deliver groundbreaking solutions in global diagnostics.
Your key responsibilities will include document control and the ability to implement robust document control processes while working closely with the Head of Quality and Regulatory Affairs establish the QMS aligned with ISO 13485 requirements, driving continuous improvement and operation excellence.
The successful candidate will also compile technical files with comprehensive documentation to support regulatory submission and product certification while conducting risk management activities in accordance with ISO 14971, identifying potential hazards, assessing risks and implementing effective mitigation strategies.
Quality andRegulatory Specialist Key Responsibilities:
Manage and organize quality and regulatory documentation
Maintain compliance with regulatory requirements
Collaborate with teams for regulatory compliance training
Maintain compliance throughout the product lifecycle
Quality and
Regulatory Specialist Requirements:
Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences, Regulatory Affairs)
2 years' experience in quality and regulatory affairs within the medical device industry, preferably with exposure to software (IEC and Software as a Medical Device (SaMD)
Strong understanding of ISO 13485, ISO 14971, and other relevant regulatory standards
Detail-oriented mindset with a commitment to maintaining the highest standards of quality and compliance
Experience with CE marking processes and regulatory submissions is highly desirable
This is an exciting opportunity to be part of a dynamic and innovative company dedicated to making a meaningful impact on the lives of millions affected by diabetes.
If you are driven by excellence, passionate about regulatory compliance, and eager to contribute to the future of healthcare, the Head of Quality and Regulatory Affairs is driven to help you develop your career with a clear pathway set to develop up to a managerial level.