Regulatory Affairs Director

3 weeks ago


Cardiff, Cardiff, United Kingdom Stirling Q&R Full time

Job Summary

Stirling Q&R is seeking a highly skilled Regulatory Affairs Manager to lead the company's transition to EU-MDR requirements, manage a team of UK staff, and serve as a deputy Person Responsible for Regulatory Compliance (PRRC). This role involves overseeing regulatory compliance, submissions, and strategies for medical devices.

Key Responsibilities

  • Develop and maintain regulatory knowledge of European, FDA, and country-specific regulations.
  • Lead company transition to EU-MDR requirements.
  • Coordinate and prepare regulatory submissions and strategies.
  • Manage a team of UK staff.
  • Act as deputy PRRC, including:
    • Developing continuous improvement processes for product quality and regulatory compliance.
    • Preparing and maintaining technical documentation and EU Declaration of Conformity.
    • Meeting post-market surveillance obligations.
  • Identify compliance issues and conduct or direct required investigations.
  • Serve as a point of contact for employees on compliance matters.
  • Review and modify policies to comply with changing standards and regulations.
  • Stay informed about industry trends and assess their impact on organizational processes.

Requirements

Qualifications and Skills

  • Advanced degree in a relevant field (e.g., Biomedical Engineering, Pharmacy, Life Sciences).
  • Extensive experience in regulatory affairs within the medical device industry.
  • In-depth knowledge of EU-MDR and FDA regulations.
  • Strong leadership and team management skills.
  • Excellent communication and interpersonal skills.
  • Ability to interpret and apply complex regulatory requirements.

Benefits

  • Pension Plans.
  • Work From Home.
  • Training & Development.


  • Cardiff, Cardiff, United Kingdom Stirling Q&R Full time

    Position OverviewStirling Q&R is seeking a highly skilled Regulatory Affairs Manager to oversee regulatory compliance, submissions, and strategies for medical devices. This role involves leading the company's transition to EU-MDR requirements, managing a team of UK staff, and serving as a deputy Person Responsible for Regulatory Compliance (PRRC).Key...


  • Cardiff, Cardiff, United Kingdom Stirling Q&R Full time

    Job SummaryThe Regulatory Affairs Manager at Stirling Q&R is responsible for ensuring compliance with regulatory requirements for medical devices. This role involves leading the company's transition to EU-MDR requirements, managing a team of UK staff, and serving as a deputy Person Responsible for Regulatory Compliance (PRRC).Key ResponsibilitiesDevelop and...


  • Cardiff, Cardiff, United Kingdom Yolk Recruitment Full time

    Regulatory Affairs ProfessionalYolk Recruitment is partnering with a pioneering medical device business to fill a new opportunity for a Regulatory Affairs Specialist. This role offers the chance to be part of a high-growth, high-innovation business in a rewarding field, providing guidance on a wide range of regulatory affairs.Key Responsibilities:* Lead...


  • Cardiff, Cardiff, United Kingdom Yolk Recruitment Ltd Full time

    Yolk Recruitment Ltd is seeking a highly skilled Regulatory Affairs Specialist to join a pioneering medical device business during an exciting period of sustained expansion.The successful candidate will support NPD projects, guiding others to ensure product compliance and support audits, developing RA strategies to govern the continued development of...


  • Cardiff, Cardiff, United Kingdom Ramboll Group AS Full time

    Senior Consultant (m/f/d) Chemical Regulatory AffairsWe are seeking a highly skilled and experienced Senior Regulatory Affairs Consultant to join our Health Sciences department. As a key member of our team, you will be responsible for providing subject matter expertise in chemical legislation, developing authorisation strategies, and compiling...


  • Cardiff, Cardiff, United Kingdom Ramboll Group AS Full time

    Senior Regulatory Affairs ConsultantAre you a seasoned professional with expertise in chemical legislation and regulatory affairs? We invite you to bring your experience to our team as a Senior Regulatory Affairs Consultant.About the Role:We are seeking a highly skilled individual to provide subject matter expertise in chemical legislation, develop...


  • Cardiff, Cardiff, United Kingdom Hunter Selection Full time

    Job Title: Regulatory Affairs Specialist We are currently seeking an experienced Regulatory Affairs Specialist to join our rapidly growing organisation. As a key member of our team, you will be responsible for designing and implementing QMS for design control, preparing and maintaining technical files, and ensuring continuous compliance. Main...


  • Cardiff, Cardiff, United Kingdom Yolk Recruitment Ltd Full time

    Regulatory Affairs Specialist OpportunityYolk Recruitment Ltd is partnering with a pioneering medical device business to find a Regulatory Specialist to support the team's growth and innovation.This exciting role offers the chance to work with a high-growth company in a rewarding field, providing guidance on regulatory affairs and ensuring product...


  • Cardiff, Cardiff, United Kingdom Yolk Recruitment Full time

    Regulatory Affairs Specialist OpportunityYolk Recruitment is partnering with a pioneering medical device business to fill a Regulatory Specialist role. This exciting opportunity is ideal for a candidate with experience in regulatory affairs, looking to make their mark in a leading company.The successful candidate will provide guidance on a wide range of...


  • Cardiff, Cardiff, United Kingdom Creditsafe Full time

    Service Delivery Team LeadAre you a seasoned IT professional looking to take on a leadership role? Do you have a passion for delivering exceptional service and driving business growth? We're seeking a highly skilled Service Delivery Team Lead to join our team at Creditsafe.About the RoleAs a Service Delivery Team Lead, you will be responsible for managing...

  • Area Director

    3 weeks ago


    Cardiff, Cardiff, United Kingdom Appoint Group Full time

    Job Title: Area DirectorJob Summary:We are seeking an experienced Area Director to oversee the operations and strategic direction for a portfolio of care homes in the healthcare sector. As the successful candidate, you will play a pivotal role in ensuring the delivery of high-quality care services while maintaining compliance with regulatory standards.Key...


  • Cardiff, Cardiff, United Kingdom Knoell Full time

    Job SummaryWe are seeking a highly skilled Product Safety Specialist to join our team at Knoell. As a key member of our regulatory affairs team, you will be responsible for supporting the registration of industrial chemicals according to UK REACH and EU REACH Regulation.Key ResponsibilitiesSupport the registration of industrial chemicals according to UK...


  • Cardiff, Cardiff, United Kingdom Appoint Group Full time

    Job Title: Senior Care Homes DirectorAs the Senior Care Homes Director, you will play a pivotal role in overseeing the operations and strategic direction for a portfolio of care homes in Wales. Your primary responsibility will be to ensure the delivery of high-quality care services while maintaining compliance with regulatory standards.Key...


  • Cardiff, Cardiff, United Kingdom Appoint Group Full time

    Job Title: Area DirectorJob Summary:We are seeking a highly experienced and skilled Area Director to lead our portfolio of care homes in Wales. As a key member of our team, you will be responsible for overseeing the operations and strategic direction of our care homes, ensuring the delivery of high-quality care services while maintaining compliance with...


  • Cardiff, Cardiff, United Kingdom Starling Bank Full time

    About the Role:At Starling Bank, we're committed to delivering exceptional customer experiences. As our Director of Customer Resolution, you'll play a critical role in ensuring we meet the highest standards of customer satisfaction. This is a strategic position that requires a deep understanding of complaints handling processes in a regulated environment.Key...


  • Cardiff, Cardiff, United Kingdom Salutem Shared Services Full time

    Job Title: Senior Service Reliability DirectorAbout the Role:As a Senior Service Reliability Director at Salutem Children's Services, you will lead and manage our care teams, ensuring exceptional care and support for our children and young people.Key Responsibilities:- Oversee daily operations, ensuring compliance with regulations- Foster a trauma-informed,...


  • Cardiff, Cardiff, United Kingdom Cityscape Full time

    About Cityscape:Cityscape is a leading remediation and brownfield contractor in the UK, established for over 25 years. Our expertise lies in the treatment of contaminated soil and groundwater using various chemical and biological processes. We also offer a full package including demolition and site re-grading. Our client base includes petro-chem refineries,...


  • Cardiff, Cardiff, United Kingdom Hanson Lawrie Full time

    Executive Director of OperationsWe are seeking a highly experienced and strategic Executive Director of Operations to lead our Care Home Group in Wales. As a key member of our leadership team, you will be responsible for driving high performance across all Homes, working closely with Regional Operations Managers to deliver compliant, compassionate care and...


  • Cardiff, Cardiff, United Kingdom Head4Talent Full time

    We are seeking a highly skilled Senior Financial Director to join our team at Head4Talent. This is a fantastic opportunity for a seasoned finance professional to take on a leadership role and drive the financial strategy of our organization.Key Responsibilities:Support the leadership team in driving the financial strategy and making key decisionsOversee the...


  • Cardiff, Cardiff, United Kingdom Hunter Selection Full time

    Job Title: Senior Software DeveloperAt Hunter Selection, we are seeking an experienced Senior Software Developer to join our team. This is a fantastic opportunity for a skilled software engineer to work on a product with a genuine positive impact on the end user.Key Responsibilities:Deliver NPD projects from discovery to product launch, preparing the...