Quality Assurance Regulatory Affairs Coordinator Job at 360 Resourcing Solutions (Oxford)

Quality Assurance Regulatory Affairs Coordinator

We are looking for a highly organised and proactive Quality Assurance Regulatory...

Location

United Kingdom , Oxford

Salary:

30000.00 - 40000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

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

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

Manager, Regulatory Affairs & Quality Assurance

NYES is seeking an accountable and specialized Manager of Regulatory Affairs & Q...

Location

United States , Brooklyn

Salary:

Not provided

New York Embroidery Studio

Expiration Date

Until further notice

Requirements

5–10 years of specific experience in Regulatory Affairs for PPE manufacturing, with a proven track record of successful FDA clearances
Comprehensive knowledge of FDA Class I and II medical device classifications, ASTM testing methods, and NIOSH approval standards
Strong background in implementing and maintaining Quality Management Systems (QMS) compliant with federal standards (21 CFR 820) and international standards (ISO 13485)
RAPS (Regulatory Affairs Certification) and Six Sigma Black Belt (preferred)
A professional who seeks full accountability and can coordinate complex, cross-functional teams to achieve compliance goals

Job Responsibility

Serve as the primary lead for the development, implementation, and continuous improvement of the ISO 13485 Quality Management System, ensuring all manufacturing and quality processes maintain international certification
Lead the preparation and submission of FDA 510(k) premarket notifications for medical-grade PPE (e.g., surgical masks, isolation gowns, etc.) to ensure products are “FDA-cleared.”
Oversee adherence to 21 CFR Part 820 (Quality System Regulation) for all PPE manufacturing processes and controls
Manage the certification and approval process with NIOSH for respiratory protective devices, such as N95 respirators
Ensure materials meet rigorous ASTM International standards for barrier performance, including fluid resistance (ASTM F903) and viral penetration (ASTM F1671)
Act as the primary point of contact for government agencies, ensuring manufacturing and marketing practices align with OSHA requirements
Direct the development of labeling and packaging to ensure accurate regulatory claims and prevent the marketing of unverified equipment
Partner with product development and commercial teams to navigate registration processes and ensure timely product launches

New

Quality Assurance Coordinator

The Quality Assurance Coordinator is responsible for supporting customer quality...

Location

United States , El Segundo

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor's degree in Food Science, Biology, Microbiology, Quality Assurance, or a related field preferred.
2–4 years of experience in Quality Assurance, Food Safety, Regulatory Affairs, or Quality Documentation within the food manufacturing industry.
Experience maintaining technical documentation and customer compliance records.
Working knowledge of HACCP, FSMA, FDA regulations, and food safety programs
familiarity with SQF, MSC, ASC, or BAP is a plus.
Experience using ERP systems such as SAP is preferred.
Proficient in Microsoft Office Suite, particularly Excel, Word, and Outlook.
Strong organizational skills with exceptional attention to detail.
Excellent written and verbal communication skills with the ability to coordinate across multiple departments and suppliers.
Ability to prioritize multiple deadlines and manage competing priorities in a fast-paced environment.

Job Responsibility

Customer QA Platform Management (50%): Maintain and update customer web-based quality assurance platforms by uploading product specifications, technical documentation, certifications, and regulatory records.
Ensure customer portals remain current, accurate, and compliant with customer requirements and internal quality standards.
Coordinate with domestic and international suppliers to obtain required documentation and certifications.
Communicate project timelines, documentation requirements, and deadlines to suppliers and internal stakeholders.
Monitor outstanding documentation requests and proactively follow up to ensure timely completion.
Escalate delays or documentation issues to Quality Assurance leadership as needed.
Documentation & Administrative Support (20%): Review and organize supplier technical documentation for completeness and accuracy.
Assist with maintaining product specifications and supporting documentation for new and existing products.
Coordinate updates to technical documentation to align with FDA regulations, customer requirements, and company quality standards.
Support documentation related to HACCP, FSMA, MSC, ASC, BAP, and other applicable food safety programs.

What we offer

medical, vision, dental, and life and disability insurance
401(k) plan

Fulltime

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
Experience in a clinical stage biotech company preferred
10+ years of relevant experience in clinical/GCP quality
Outstanding expertise in GCP R3 and solid understanding of PV regulations
Demonstrated ability to successfully partner cross-functionally
Excellent interpersonal effectiveness, including exceptional communication skills
Advanced computer skills, including experience working in Veeva
Consistent excellent judgement and pragmatic, risk-based decision making skills
Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities

Job Responsibility

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
Support health authority inspections, including document review, response coordination, and follow-up remediation activities
Serve as the Clinical QA Lead for assigned studies and programs
Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
Support TMF migration activities, as required
Lead quality investigations, root cause analysis, and CAPA development

Fulltime

Senior Regulatory Affairs Associate - CMC biologics/vaccines

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Serbia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University-level education, preferably in Life Sciences, or equivalent by experience
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry
Strong understanding of CMC and post-approval regulatory requirements
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
Knowledge of biological or vaccines processes
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation
Understanding of qualification/validation principles
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued
Team spirit, flexibility, accountability, and organizational skills
Fluent in English (written and spoken)

Job Responsibility

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports
Assess change controls and provide regulatory assessments of quality changes in production and quality control
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions
Identify, escalate, and mitigate risks associated with regulatory procedures and activities

What we offer

flexibility of working remotely
supportive and dynamic team
challenging assignments
mentorship from experienced regulatory professionals

Fulltime

Regulatory Affairs Consultant - CMC vax/bio (home or office based)

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University-level education, preferably in Life Sciences, or equivalent by experience
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry
Strong understanding of CMC and post-approval regulatory requirements
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
Knowledge of vaccines or biological processes - must
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation
Understanding of qualification/validation principles
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued
Team spirit, flexibility, accountability, and organizational skills
Fluent in English (written and spoken)

Job Responsibility

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports
Assess change controls and provide regulatory assessments of quality changes in production and quality control
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions
Identify, escalate, and mitigate risks associated with regulatory procedures and activities

What we offer

Flexible work arrangements

Fulltime

Regulatory Affairs Senior Officer

Reporting to the Head of Regulatory Filings, located in Jersey, you will be resp...

Location

Luxembourg , Luxembourg

Salary:

Not provided

Alter Domus

Expiration Date

Until further notice

Requirements

A minimum of 5 years of experience in Financial Services, with a minimum of 2 years in a Regulatory Compliance or Filings execution role
Solid technical knowledge and practical experience in operational regulatory compliance and filing requirements (not just strategic framework design)
Exceptional organizational skills and unwavering attention to detail are critical for register maintenance and filing accuracy
Proven track record of independently and accurately executing complex, repetitive compliance tasks and meeting strict deadlines
The ideal candidate must demonstrate a passion for continuous learning and professional development
Demonstrate clear, concise, and professional communication skills, especially in articulating data requirements and status updates to stakeholders
Strong practical analytical abilities to identify and resolve data discrepancies or filing issues quickly

Job Responsibility

Ensure the correct discharge of all regulatory processes, including all relevant regulatory notices, applications, and files
Execute the preparation, quality assurance and timely submission of regulatory filings, notices, and applications, ensuring all documentation is complete, accurate, and ready for review by the Head of Regulatory affairs (located in Jersey)
Assist the Head of Regulatory affairs in the maintenance of the centralized regulatory register, accurately tracking all incoming and outgoing regulatory notices, applications, and compliance activities
Ensure strict adherence to the global compliance framework developed by the Regulatory Affairs team, including following all defined processes, timelines, and reporting responsibilities
Maintain comprehensive, audit-ready files and supporting documentation for all regulatory submissions
Support the Regulatory Affairs team in implementing new processes, procedures, and systems related to regulatory filings and data management
Coordinate closely with internal stakeholders (Risk, Compliance, Legal, SMEs) to gather necessary data and sign-offs required for accurate regulatory submissions
Conduct internal checks and controls on submission data before final delivery to applicable sign-off

What we offer

Support for professional accreditations such as ACCA and study leave
Flexible arrangements, generous holidays, plus an additional day off for your birthday
Continuous mentoring along your career progression
Active sports, events and social committees across our offices
24/7 support available from our Employee Assistance Program
The opportunity to invest in our growth and success through our Employee Share Plan
Plus additional local benefits depending on your location

Fulltime

Department Manager - Diagnostics, TRIOS & Regulatory Affairs

We are seeking an experienced, people-centric, and inspiring leader to head our ...

Location

Ukraine , Kyiv

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Full-time presence in Kyiv
Fluent English
Degree in computer science, project management, or equivalent practical experience
Experience of working in an international company, preferably within the IT industry of Ukraine
Experience in medical/clinical domains (dental is a plus, but not required) will be beneficial
Strong people leadership with high emotional intelligence
credible in addressing team tensions/conflicts
Proven structured execution: ability to create clarity, routines, and transparency (planning, reporting, capacity overview)
Excellent communication and stakeholder management in environments with competing priorities
Experience working in a matrix organization (cross-border/cross-functional), ideally with HQ/functional lines outside the local site

Job Responsibility

Delivery & operational excellence (co-own): ensure predictable delivery and high operational efficiency of the department by managing throughput, quality, and capacity. Drive performance via clear operational KPIs, continuous planning, and disciplined execution in partnership with functional stakeholders
People leadership: understand individual and team motivations
coach, develop, and engage people. Implement the best practices of people management and leadership development within the department
Continuous improvement mindset: proactively identify what works/doesn't
drive improvements using data and feedback loops
Stakeholder management: clarify priorities, manage expectations, and mediate conflicting requirements across functions
Matrix coordination: work closely with functional managers to build a consolidated capacity overview and enable prioritization
Change leadership, be open-minded, and introduce new ways of working while navigating internal resistance constructively. Demonstrates a growth mindset and constructive challenge, reframes obstacles into possibilities, and stays curious rather than dismissive. Be able to identify, unlock, and reallocate scarce resources (budget, headcount, time) in constrained environments by prioritizing value, building stakeholder alignment, and negotiating trade-offs across competing demands
Local matters: Collaborate and contribute to the 3Shape UA Management Team for the benefit of all departments in 3Shape UA. Create local ties for country matters & company local arrangements (assuring local company practices and processes of HR, finance, legal, and administrative nature are onboarded within the department) together with General Manager 3Shape UA & Department Managers

What we offer

24 working days of annual vacation
medical insurance
paid sick leaves and child sick leaves
maternity and paternity leaves
Breakfasts and lunches in the office
Good working conditions in a comfortable office in UNIT.City
A parking lot with free spaces for employees
Occasional business trips to Western Europe

Fulltime

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Quality Assurance Regulatory Affairs Coordinator

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