Regulatory Affairs Senior Associate

4 weeks ago


Belfast, United Kingdom HIRANI Full time
Senior Specialist – Regulatory Affairs (IVD/CDx)

At HIRANI, we seek a highly skilled and experienced Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory team, you will provide specialized regulatory expertise to client companies, ensuring that internal procedures and client expectations are met.

The Role:

  • Support the work of our company and project teams in providing regulatory expertise to client companies.
  • Bring significant experience in IVD/CDx development, validation, and approval to client organizations, providing expert strategies and guidance to their development programs.
  • Research and prepare elements of regulatory submission documents on behalf of client companies, including IVDR Annex XIV applications, CTAs, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files, and Design Dossiers.
  • Assist the wider team in understanding regulatory requirements for investigational devices in the setup, management, and conduct of IVD performance studies/clinical investigations worldwide.
  • Manage and keep up-to-date information relating to global regulatory requirements for IVD devices and maintain our web-based clinical trial planning tool.
  • Conduct gap analyses on behalf of client companies and prepare associated reports.
  • Contribute to the preparation of other regulatory documents on behalf of client companies, such as Performance Evaluation Plans/Reports and Investigator Brochures.
  • As required, leverage professional networking opportunities to promote our company and its services to appropriate parties.
  • Design and deliver formal client presentations, including proposed solutions and client training.
  • Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards.
  • Contribute to HIRANI company culture initiatives to maintain a positive and engaging workforce.


  • Belfast, United Kingdom ARC Regulatory Ltd Full time

    Job Title: Senior Specialist- Regulatory AffairsAt ARC Regulatory Ltd, we are seeking a highly skilled and experienced Senior Specialist- Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring that our clients' medical devices and in vitro diagnostic (IVD) products comply with relevant...


  • Belfast, United Kingdom ARC Regulatory Ltd Full time

    Job DescriptionJob Title: Senior Specialist- Regulatory AffairsCompany: ARC Regulatory LtdLocation: BelfastAbout Us: ARC Regulatory Ltd is a Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector.Job Summary: We are seeking a highly experienced Regulatory Affairs Specialist to join...


  • Belfast, United Kingdom HIRANI Full time

    Senior Specialist – Regulatory Affairs (IVD/CDx)At HIRANI, we seek a highly skilled and experienced Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory team, you will provide specialized regulatory expertise to client companies, ensuring that internal procedures and client expectations are met.The role:Support the work...


  • Belfast, United Kingdom HIRANI Full time

    Senior Specialist – Regulatory Affairs (IVD/CDx)At HIRANI, we're seeking a highly skilled and experienced Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory team, you will play a crucial role in providing specialized regulatory expertise to our clients in the life and health sciences sector.The Role:Support our clients...


  • Belfast, United Kingdom HIRANI Full time

    Senior Specialist – Regulatory Affairs (IVD/CDx)At HIRANI, we're seeking a highly skilled and experienced Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory team, you will play a crucial role in providing specialized regulatory expertise to our clients in the life and health sciences sector.The Role:Support our clients...


  • Belfast, United Kingdom HIRANI Full time

    Senior Specialist – Regulatory Affairs (IVD/CDx)Hiranai seeks a highly skilled Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory team, you will provide specialized regulatory expertise to client companies, ensuring that internal procedures and client expectations are met.The Role:Support the work of our company and...


  • Belfast, United Kingdom HIRANI Full time

    Senior Specialist – Regulatory Affairs (IVD/CDx)Hiranai seeks a highly skilled Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory team, you will provide specialized regulatory expertise to client companies, ensuring that internal procedures and client expectations are met.The Role:Support the work of our company and...


  • Belfast, United Kingdom ARC Regulatory Ltd Full time

    Job DescriptionAs a key member of our team, you will play a crucial role in ensuring the compliance of our clients' medical devices with global regulations. Your expertise in IVD/CDx development, validation, and approval will be instrumental in guiding our clients through the complex regulatory landscape.Key Responsibilities:Provide specialized regulatory...


  • Belfast, United Kingdom Stryker Full time

    Job Title Regulatory Affairs Co-Op Reports To Associate Manager, Regulatory Affairs Position Summary **This is a one-year placement student opportunity.** Key Areas of Responsibility - Help develop and maintain all Sales Bills of Materials to ensure consistency for customer orders. - Assist in preparation and development of new technical documents,...


  • Belfast, United Kingdom Pharmiweb Full time

    We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment.This is a client dedicated project,...


  • Belfast, United Kingdom TP ICAP Group Services Ltd Full time

    Job Title: Regulatory Reporting Senior AssociateJoin TP ICAP Group Services Ltd as a Regulatory Reporting Senior Associate and contribute to the delivery of high-quality regulatory reporting solutions.Job SummaryWe are seeking a highly skilled and experienced Regulatory Reporting Senior Associate to join our team. As a key member of our regulatory reporting...


  • Belfast, United Kingdom TP ICAP Group Services Ltd Full time

    Job Title: Regulatory Reporting Senior AssociateJoin TP ICAP Group Services Ltd as a Regulatory Reporting Senior Associate and contribute to the delivery of high-quality regulatory reporting solutions.Job SummaryWe are seeking a highly skilled and experienced Regulatory Reporting Senior Associate to join our team. As a key member of our regulatory reporting...


  • Belfast, United Kingdom TP ICAP Group Services Ltd Full time

    Job Title: Regulatory Reporting Senior AssociateWe are seeking a highly skilled Regulatory Reporting Senior Associate to join our team at TP ICAP Group Services Ltd. As a key member of our Regulatory Reporting team, you will be responsible for ensuring the accuracy, completeness, and timeliness of our regulatory reporting outputs.Key Responsibilities:Ensure...


  • Belfast, United Kingdom TP ICAP Group Services Ltd Full time

    Job Title: Regulatory Reporting Senior AssociateJob Summary:We are seeking a highly skilled Regulatory Reporting Senior Associate to join our team at TP ICAP Group Services Ltd. As a key member of our regulatory reporting team, you will be responsible for ensuring the accuracy, completeness, and timeliness of our regulatory reporting outputs.Key...


  • Belfast, United Kingdom TP ICAP Group Services Ltd Full time

    Regulatory Reporting Senior Associate Job DescriptionTP ICAP Group Services Ltd is seeking a highly skilled Regulatory Reporting Senior Associate to join our team. As a key member of our Regulatory Reporting team, you will be responsible for delivering high-quality regulatory reporting outputs, ensuring accuracy, timeliness, and completeness.Key...


  • Belfast, United Kingdom TP ICAP Group Services Ltd Full time

    Job Title: Senior Associate - Regulatory ReportingJob Summary:The TP ICAP Group is a world-leading provider of market infrastructure. We are seeking a highly skilled Senior Associate to join our Regulatory Reporting team. The successful candidate will be responsible for delivering Quality Assurance (QA) activities, identifying, designing, and implementing...


  • Belfast, United Kingdom TP ICAP Full time

    Job OverviewThe TP ICAP Group is a leading provider of market infrastructure, aiming to provide clients with access to global financial and commodities markets. Our purpose is to improve price discovery, liquidity, and data distribution through responsible and innovative solutions. Through our people and technology, we connect clients to superior liquidity...

  • Legal Counsel

    2 weeks ago


    Belfast, United Kingdom Citi Full time

    Role OverviewAs a member of Citi's Regulatory Advisory Legal Team, you will provide technical legal advice on banking & financial services regulatory change developments impacting Citi.About the TeamThe Regulatory Advisory Legal Team supports Citi business lines, legal entity management teams, Compliance, Government & Public Affairs and Regulatory Engagement...


  • Belfast, United Kingdom TP ICAP Full time

    Job OverviewThe TP ICAP Group is a leading provider of market infrastructure solutions. Our purpose is to deliver innovative and responsible solutions to clients, improving price discovery, liquidity, and data distribution. Through our people and technology, we connect clients to superior liquidity and data solutions.We operate from over 60 offices in 27...


  • Belfast, United Kingdom 7twenty Professional Search Full time

    Job Role: Corporate Affairs ManagerWe are partnering with a leading infrastructure organisation to appoint a Corporate Affairs Manager. Our client operates as a vital gateway for business and leisure passengers, providing significant contributions to the country's prosperity. The successful candidate will be responsible for delivering the public affairs...