Regulatory Assurance Specialist

hace 5 días


Madrid, Madrid, España Vision Achievement A tiempo completo
Job Title:

Regulatory Assurance Specialist - Life Sciences

About Us:

Vision Achievement is a leading provider of regulatory and quality assurance services to the life sciences industry.

Compensation:

The estimated annual salary for this position is $120,000 - $180,000, depending on experience.

Job Description:

We are seeking an experienced Regulatory Assurance Specialist to join our team. In this role, you will be responsible for providing expert guidance on regulatory and quality assurance infrastructure, ensuring compliance with relevant regulations and standards.

Responsibilities:
  • Provide expert consulting services in the RA/QA domains, specifically focusing on medical devices, in vitro diagnostics, lab-developed tests, pharmaceuticals, and cosmetics.
  • Investigate Out of Specification (OOS) and Out of Trend (OOT) results, considering potential errors in calculation, method/procedure, instrumentation, and sampling.
  • Ensure adherence to relevant 21 CFR 2XX and 8XX sections.
Requirements:
  • Bachelor's degree in Engineering, Science, or a related Life Sciences field.
  • Demonstrated progression in responsibilities, such as leading regulatory submissions.
  • Significant RA/QA experience in medical devices, in vitro diagnostics, pharmaceuticals, or cosmetics.
Benefits:

This is a full-time, remote position with competitive compensation and benefits. We offer opportunities for professional growth and development in a dynamic and flexible work environment.



  • Madrid, Madrid, España Ferring Pharmaceuticals A tiempo completo

    Ferring Pharmaceuticals is a global leader in reproductive and women's health, gastroenterology, and urology. We are seeking a Quality Assurance Specialist to support our team in Madrid, Spain.Job Description:We are looking for a skilled Quality Assurance Specialist to manage our system of procedures, prepare and review SOPs, and conduct change requests. The...


  • Madrid, Madrid, España Ferring Pharmaceuticals A tiempo completo

    Job Description: Ferring Pharmaceuticals seeks a Quality Assurance & Regulatory Affairs Specialist to support and contribute to the Quality and Regulatory Affairs team. Key responsibilities include managing the company's system of procedures, preparing and reviewing SOPs, and monitoring submitted variations to obtain approvals. Requirements:- Health Sciences...


  • Madrid, Madrid, España Ferring Pharmaceuticals A tiempo completo

    At Ferring Pharmaceuticals, we are seeking a motivated and detail-oriented Regulatory Affairs & Quality Assurance Specialist to join our team. This temporary position will support the Quality and Regulatory Affairs team in Madrid, covering maternity leave.About UsWe are a global pharmaceutical company dedicated to helping people build families and live...


  • Madrid, Madrid, España Vision Achievement A tiempo completo

    At Vision Achievement, we are seeking a highly skilled Regulatory Assurance Specialist to join our team. As an independent contractor, you will be responsible for delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure.About the RoleThe ideal candidate will have significant experience in RA/QA matters related to...


  • Madrid, Madrid, España Exeltis A tiempo completo

    **Job Title:** Quality Assurance Specialist**About the Role:** We are seeking a highly skilled Quality Assurance Specialist to join our team at Exeltis. The ideal candidate will be responsible for ensuring that our quality systems are established, implemented, and maintained in each market in scope.Key Responsibilities:• Keep the documentation of the...


  • Madrid, Madrid, España Ergomed A tiempo completo

    About the RoleAs a highly skilled Regulatory Affairs Specialist, you will be responsible for ensuring the successful start-up and regulatory compliance of clinical trials. With your expertise in the pharmaceutical industry, you will play a key role in managing study start-up and regulatory deliverables.


  • Madrid, Madrid, España Exeltis A tiempo completo

    Job Overview: As a Senior Quality Assurance Specialist at Exeltis, you will play a crucial role in ensuring the establishment, implementation, and maintenance of quality systems across our markets. This position requires strong regulatory knowledge, excellent communication skills, and the ability to collaborate with cross-functional teams to drive continuous...


  • Madrid, Madrid, España Serco Group Plc A tiempo completo

    **Job Title:** Product Assurance SpecialistWe are seeking a skilled Product Assurance Specialist to support the European Space Agency (ESA) at the European Space Astronomy Centre (ESAC) in Villanueva de la Cañada, Madrid, Spain.This is an exciting opportunity to join our team and contribute to the development and operations of scientific missions. As a...


  • Madrid, Madrid, España Ergomed A tiempo completo

    About the RoleErgomed is a rapidly expanding full-service CRO specializing in Oncology and Rare Disease. As a Senior Specialist, Study Start Up and Regulatory, you will be responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan.The ideal candidate will serve as a liaison between SSU/regulatory...


  • Madrid, Madrid, España Precision Medicine Group A tiempo completo

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Spain. This role will be responsible for delivering site activation readiness within assigned countries/sites and ensuring compliance with international and local regulations.The ideal candidate will have a strong understanding of clinical trial regulations,...


  • Madrid, Madrid, España SIX Group Services Ltd. A tiempo completo

    SIX Group Services Ltd. is at the forefront of transforming financial markets in Europe.Role OverviewWe are looking for a highly skilled Regulatory Framework Specialist to join our team in Madrid. As a Regulatory Framework Specialist, you will play a pivotal role in monitoring regulatory developments and ensuring compliance for SIX Clearing across the EU,...


  • Madrid, Madrid, España Alk Nordic AS A tiempo completo

    Alk Nordic A/S is a leading global pharmaceutical company that prioritizes quality and customer satisfaction. As a Senior QA Specialist, you will play a crucial role in ensuring the performance of manufacturing, packaging operations, and product quality meets established cGMPs.About the RoleThis senior-level position requires a high level of involvement in...


  • Madrid, Madrid, España Alk Abello Spa A tiempo completo

    About the PositionAt Alk Abello Spa, we are seeking a highly skilled Quality Assurance Specialist to join our team in Madrid. The ideal candidate will have a strong background in quality systems, GMP, and regulatory requirements.Job DescriptionWe are looking for a Senior QA Specialist with high proficiency in English to provide support for and be directly...


  • Madrid, Madrid, España Dojo 2022 A tiempo completo

    About the Role:As Head of Regulatory Compliance (PCF-12) at Dojo, you will play a critical role in ensuring the company's compliance with regulatory requirements in Ireland and the European Economic Area (EEA). You will work closely with the Paymentsense Ireland Limited (PIL) board and management to enhance the Regulatory Compliance program and provide...


  • Madrid, Madrid, España Takeda A tiempo completo

    About the RoleWe are seeking a highly experienced Senior Quality Assurance Specialist to join our team in Madrid, Spain. As a key member of our Quality Assurance department, you will be responsible for ensuring that our products meet the highest quality standards and comply with all relevant regulations.Job DescriptionThe successful candidate will have at...


  • Madrid, Madrid, España Pentasia A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Pentasia. As a key member of our quality assurance department, you will play a critical role in ensuring the highest quality of our digital asset integration services.


  • Madrid, Madrid, España Exclusive Networks A tiempo completo

    Lead Data Assurance Specialist OpportunityExclusive Networks is a global cybersecurity specialist seeking a Lead Data Assurance Specialist to join its Global IT team. As a champion of data quality assurance, you will play a key role in ensuring the accuracy and consistency of our organization's data assets.Responsibilities:Assessing and improving data...


  • Madrid, Madrid, España Vision Achievement A tiempo completo

    Job Description:    At Vision Achievement, we are seeking an experienced Regulatory Compliance Specialist to join our team. This exciting role offers a unique opportunity to work with clients in the life sciences industry, providing expert guidance on quality and regulatory affairs.About the Role:    As a Regulatory Compliance Specialist, you will be...


  • Madrid, Madrid, España Bitfinex A tiempo completo

    Bitfinex is a leading digital asset trading platform offering cutting-edge services for global liquidity providers and cryptocurrency traders. We are seeking an organized self-starter to join our Regulatory and Licensing team as a Regulatory Compliance Specialist. The successful candidate will have a deep understanding of legal and regulatory requirements...


  • Madrid, Madrid, España Parexel International A tiempo completo

    Job TitleRegulatory ManagerCompany OverviewParexel International is seeking a highly skilled Regulatory Manager to join our dynamic team.Estimated Salary$80,000 - $110,000 per year based on experience and location in Europe.About the RoleWe are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to play a vital role in our...