CrawlJobs Logo

Medical Device Regulatory Administrator

United Kingdom, Gosmore Employment contract · Job Posted July 05, 2026
Apply Position
Job Link Share

Job Description

Exciting Opportunity: Medical Device Regulatory Administrator. Are you a highly organised administrator with excellent attention to detail and a passion for working in a regulated environment? This growing healthcare organisation is seeking a Regulatory & Quality Administrator to join its Clinical and Regulatory Affairs team, providing vital support across product safety, quality, and regulatory processes. This is a fantastic opportunity for someone with strong administrative skills who wants to build experience within a regulated healthcare environment. You'll gain exposure to regulatory processes, quality systems, document control, and cross-functional project coordination while working within a supportive and collaborative team.

Job Responsibility

  • Managing and recording customer feedback relating to product quality and safety matters
  • Coordinating communication between internal departments, customers, distributors, and external partners
  • Maintaining document control systems, including SOPs, work instructions, and other controlled documents
  • Supporting the preparation of reports and data summaries used for monitoring product performance and quality trends
  • Reviewing regulatory standards, specifications, and guidelines, and assisting with gap analysis activities
  • Supporting artwork review and approval processes
  • Conducting document checks prior to manufacturing activities to ensure compliance requirements are met
  • Maintaining databases and ensuring records remain accurate, complete, and up to date

Requirements

  • Previous experience in an administrative, document control, compliance, quality, or regulatory support role
  • Strong organisational skills with the ability to manage multiple priorities simultaneously
  • Excellent verbal and written communication skills
  • High levels of accuracy and attention to detail
  • Confidence using Microsoft Office applications, particularly Word and Excel
  • Experience working with databases and electronic record systems
  • The ability to work independently while collaborating effectively with multiple teams

Nice to have

Experience in Pharmacovigilance, Medical Devices, Regulatory Affairs, or a scientific discipline

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Medical Device Regulatory Administrator

8 matching positions

Quality Assurance & Regulatory Affairs Administrator

We are recruiting for a Quality Assurance & Regulatory Affairs Administrator to ...
Location
Location
United Kingdom , Sunbury-on-Thames
Salary
Salary:
28000.00 - 33000.00 GBP / Year
workshoprecruitment.co.uk Logo
workshop recruitment
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience working in a regulated industry (medical devices, pharmaceutical, life sciences or similar)
  • Understanding of ISO 13485, EU MDR or FDA quality requirements
  • Strong organisational and administrative skills
  • Excellent attention to detail
  • Confident using Microsoft Office (Word, Excel, Outlook, Teams)
Job Responsibility
Job Responsibility
  • Maintain and update the Quality Management System (QMS) in line with ISO 13485
  • Manage document control processes, ensuring accurate revision and distribution of documents
  • Support CAPA, non-conformance, complaints and change control processes
  • Assist with internal and external quality audits
  • Maintain training records and compliance documentation
  • Support regulatory submissions and product registrations
  • Monitor regulatory updates and support ongoing compliance activities
What we offer
What we offer
  • On site Parking
  • Hybrid Working
  • Fulltime
Read More
Arrow Right

Medical, Legal, and Regulatory Specialist

The Medical, Legal, and Regulatory (MLR) Specialist supports the MLR team by wor...
Location
Location
Poland , Warsaw
Salary
Salary:
122000.00 - 201000.00 PLN / Year
exactsciences.com Logo
Exact Sciences
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree in business administration or field as outlined in the essential duties
  • or High School Diploma or General Education Degree (GED) and 4 years of experience in lieu of Bachelor's degree
  • 2+ years of experience working in commercial (sales, marketing, commercial operations), compliance, or related field
  • 1+ years of experience in material review (MLR) specific collaborative and matrixed environment
  • Demonstrated success with oral and written communications/presentations, results orientation, facilitation, and teamwork skills
  • Basic computer skills to include Internet navigation, Email usage, and word processing
  • Demonstrated ability to perform the essential duties of the position with or without accommodation
  • Authorization to work in the United States without sponsorship
Job Responsibility
Job Responsibility
  • Acts as a liaison between internal and external stakeholders of the MLR process to ensure timely and accurate review of advertising and promotional material meets internal guidelines and requirements
  • Partner with Medical, Regulatory Affairs, Legal and Commercial to assess and determine need for process review of materials
  • Manage the ECMS submission process to ensure all content metadata and deliverables are included within project requirements
  • Schedule and lead MLR meetings, prepare agendas, and consolidate meeting minutes at the direction of Leadership
  • Responsible for coordinating and holding weekly and ad-hoc meetings
  • Manage multiple shared inboxes related to the MLR process
  • Responsible for creating weekly reports that will be sent out to all functions within the MLR area
  • Maintain organized project management related information and provide to appropriate stakeholders
  • Facilitate timely reviews and approvals by coordinating with internal and external teams
  • Coordinate and provide communication updates to user groups, management, and project teams
What we offer
What we offer
  • Discretionary bonus under applicable company plans
  • Fulltime
Read More
Arrow Right
New

Full Time OR Core Technologist

Join our growing team as a Full Time OR Core Technologist!
Location
Location
United States , Meriden
Salary
Salary:
32.00 - 48.85 USD / Hour
midstateradiology.com Logo
Meriden, Connecticut.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent
  • Graduate AMA approved radiology program
  • Registered with American Registry of Radiological Technologists (ARRT)
  • CT state license
  • CPR certification may be required
  • Maintenance of continuing education credits as required by licensure
  • Individual exceptions may apply only under the discretion of the Medical and Administrative Director
Job Responsibility
Job Responsibility
  • Performs diagnostic radiography studies by following established protocols and selecting correct exposure factors utilizing the assessment of patient age and diagnosis to produce a technically excellent image to assist the radiologist in the diagnosis
  • Participates in complex invasive OR and Hybrid procedures by assisting the MD in performing the procedure and producing images in order to provide therapeutic and diagnostic services
  • Practices radiation safety through appropriate use of radiation protection devices and adhering to radiation safety standards in order to protect patient, self and staff and to comply with regulatory agencies and requirements
  • Maintains the radiological equipment in good operating order
  • Demonstrates yearly competencies, including knowledge and behaviors, to conduct examinations and meet the needs of patients with regard to the patient's age, condition or other special requirements
  • Routinely prepares examination for interpretation by the radiologist to include correct identification and processing
  • Possess computer skills appropriate to meet departmental needs in preparation of reports and correspondence
  • Works effectively as a team member within the department and with other units to provide quality service through communication, cooperation and collaboration
  • Provides clinical supervision and instruction to students by maintaining and understanding of policies, procedures, and the clinical competency process
What we offer
What we offer
  • Up to $10,000 Sign On Bonus
  • competitive shift differentials (12% – 50% of base rate)
  • Fulltime
Read More
Arrow Right
New

Document Controller

We are looking for a detail-focused Document Controller to support documentation...
Location
Location
United States , Huntersville
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in document control, records administration, quality documentation, or a similar support function
  • Strong working knowledge of Microsoft Office, with particular strength in Word and Excel
  • Excellent organizational skills with a high level of accuracy and attention to detail
  • Ability to locate, retrieve, and manage files efficiently within electronic document systems
  • Comfortable working within regulated settings such as healthcare, medical device, pharmaceutical, manufacturing, or related industries
  • Ability to balance competing priorities and adjust to shifting deadlines
  • Strong written and verbal communication skills with a service-oriented approach to internal support
Job Responsibility
Job Responsibility
  • Oversee controlled documents within electronic filing systems and keep records current, organized, and readily accessible
  • Maintain logical folder structures and document repositories to support efficient storage and retrieval of quality-related files
  • Assign and monitor change control identifiers while ensuring associated records are properly documented and tracked
  • Prepare, revise, and format documentation using Microsoft Word and Excel to support consistency and accuracy
  • Create and maintain labels through Bartender software when required for documentation or operational needs
  • Provide controlled documents to internal teams upon request and help ensure the correct versions are distributed
  • Coordinate document updates through revision, approval, and version control workflows
  • Review documentation practices for alignment with internal quality expectations and applicable regulatory standards
  • Work closely with Quality and Engineering stakeholders to preserve accurate documentation across active projects
  • Manage multiple documentation priorities at once while meeting deadlines in a fast-paced environment
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right
New

Quality Assurance Regulatory Affairs Coordinator

Location
Location
United Kingdom , Oxford
Salary
Salary:
30000.00 - 40000.00 GBP / Year
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proactive and able to manage multiple priorities effectively
  • Comfortable working in a fast-paced, regulated environment
  • Excellent IT skills, ability to use MS Office and pick up bespoke systems with ease
Job Responsibility
Job Responsibility
  • Develop and deliver QARA training and inductions on core QMS processes, procedures, and requirements
  • Create and maintain training materials, ensuring accurate and up-to-date training records across the business
  • Provide administrative support to ensure regulatory affairs (RA) activities and timelines are effectively managed
  • Support the development, implementation, and continuous improvement of QARA strategies and the QMS
  • Ensure compliance with local, national, and international regulations, monitoring regulatory changes and assessing their impact
  • Fulltime
Read More
Arrow Right

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...
Location
Location
United States , Skaneateles Falls
Salary
Salary:
208000.00 - 286000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
  • medical device preferred)
  • Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
  • Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
  • Possesses expert knowledge of research objectives, protocol design, and data collection standards
  • Experience reviewing monitoring reports
  • High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
  • Able to monitor performance of team in maintaining system updates to allow for senior management reports
  • Applies current applications/systems to compile information for presentation or distribution
  • Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
Job Responsibility
Job Responsibility
  • Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
  • Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
  • Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
  • Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
  • Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources
  • Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
  • Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
  • Lead Clinical Study Execution team(s) to develop clinical strategies and project plan
  • Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project
  • Facilitate preparation of protocols including study design, case report forms, study procedures
What we offer
What we offer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Fulltime
Read More
Arrow Right

Strategic Account Manager

Our mission is to Profoundly change the standard of care by creating a tomorrow ...
Location
Location
United States , Houston
Salary
Salary:
Not provided
profoundmedical.com Logo
Profound Medical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 3 - 5 years of experience in healthcare program management, capital equipment sales, or clinical account management
  • Strong knowledge of hospital operations, clinical workflows, and healthcare technology adoption
  • Proven ability to build relationships with physicians, administrators, and cross-functional teams
  • Excellent communication, presentation, and problem-solving skills
  • Ability to travel up to 50%, dependent on account and site distribution
  • PMP certification or equivalent is an asset
  • Experience with Class II/III medical devices and controlled product development processes preferred
  • Familiarity with urology or oncology clinical environments preferred
  • Proficiency in MS Project, ERP systems, and CRM tools
  • Demonstrated success in solution-selling and strategic account management
Job Responsibility
Job Responsibility
  • Support the lifecycle of TULSA-PRO® implementation at clinical sites, including installation, workflow integration, and ongoing program optimization
  • Build and maintain strong relationships with physicians, hospital administrators, and clinical staff to drive utilization and adoption
  • Act as point person for hospitals and clinical teams, ensuring alignment with program goals, timelines, and compliance standards
  • Execute account-specific strategies to grow program awareness and procedural volume
  • Coordinate cross-functional teams (clinical, engineering, marketing, regulatory) to meet project milestones and deliverables
  • Assist with physician and staff training programs to ensure proficiency and adoption of TULSA-PRO® technology
  • Track and report on program performance, including clinical outcomes, utilization metrics, and financial performance
  • Ensure adherence to regulatory requirements, design controls, and internal SOPs
  • Represent TULSA-PRO® at marketing events, executive meetings, and presentations to demonstrate value propositions and support hospital system approval
  • Identify opportunities for system upgrades, additional installations, and service expansions
  • Fulltime
Read More
Arrow Right

Working Student – Upstream Marketing & Project Management (GEOX)

As a Working Student in Upstream Marketing, you will support strategic and opera...
Location
Location
Germany , München
Salary
Salary:
Not provided
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Enrolled student in Marketing, Business Administration, Biomedical Engineering, or related field
  • Strong interest in medical devices, healthcare marketing, and upstream strategy
  • Having excellent organizational and project management skills would be desirable
  • Analytical mindset with attention to detail and ability to structure complex topics
  • Strong communication skills and ability to work in cross-functional, international teams
  • Proficiency in Copilot, PowerPoint and Excel
  • familiarity with project management tools is a plus
  • Fluent in English (German is a plus)
Job Responsibility
Job Responsibility
  • Support end-to-end project management of GEOX-related initiatives (planning, tracking, and execution)
  • Assist in cross-functional coordination with Marketing, R&D, Regulatory Affairs, and regional teams
  • Contribute to the development of value propositions, messaging, and upstream marketing materials
  • Prepare presentations, reports, and business case inputs for internal stakeholders
  • Conduct market research, competitor analysis, and customer insights generation
  • Support portfolio and product lifecycle activities (e.g., launches, updates, sustaining initiatives)
  • Track project milestones, timelines, and performance indicators
  • Assist in maintaining structured documentation and project tools (e.g., Copilot, SharePoint, Excel, project trackers)
  • Parttime
Read More
Arrow Right