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

Quality Assurance Specialist, Medical Communications

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experienced Medical Writer (1-2 years)
Scientific background and degree (PharmD, MD, PhD or Masters)
Knowledge of IT and digital solutions
Strong attention to detail and accuracy
Ability to manage and prioritize multiple, detailed activities
Results-orientated with fast and focused execution
Good communication, coordination and time management skills
Ability to work within a team or across multiple teams (including remotely) as well as independently
Fluent in oral and written English with high level of communication skills
Values teamwork, collaboration, and innovation

Job Responsibility

Cross check scientific information against cited references and ensure medical accuracy (fact check)
Ensure consistency with product label where applicable
Verify presence of essential information
Correct interpretation of scientific data from reference/sources
Alignment/formatting of content as per style guides/journal guidelines/congress guidelines
Ensure consistency of scientific content across different sections (including text, figures, tables)
Accurate bibliography/in-text citation and alignment of figures/graphs as per branding guidelines
Confirm that every sentence is source annotated, and each source annotation matches with respective reference and vice versa
Ensure that information is presented in a neutral manner without any interpretations and/or author’s conclusion
Track work and communicate with client team on job reviews, prioritization etc., through emails and teleconferencing if needed

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

New

Senior Regulatory Affairs Specialist

Reporting to the Senior Manager, Regulatory Affairs within the RA Department, th...

Location

United States , St Louis

Salary:

74000.00 - 90000.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Self-starter with demonstrated organizational, project management, time management and problem-solving skills
Experience working effectively on cross-functional teams
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
Understanding of chemical / scientific industry
Experience with internal audit process and quality systems
Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries

Job Responsibility

Identify regulatory requirements for new products or product enhancements early in the product development cycle
Assure that product registration and maintenance fees are tracked and paid
Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims
Review product revision requests to assure compliance with regulatory requirements
Work on product teams to develop regulatory strategy based on regulatory submission requirements
Review and approve labeling and marketing literature
Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
Other duties as assigned

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

GCP QA Consultant

Proclinical is seeking a GCP QA Consultant to support quality assurance activiti...

Location

Germany , Berlin

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong knowledge of ICH-GCP guidelines and regulatory requirements
Experience in quality assurance for clinical trials, particularly in phase 2-3 studies
Proficiency in risk management and quality oversight processes
Ability to manage and maintain TMF documentation and ensure inspection readiness
Skilled in identifying deviations, implementing corrective actions, and driving process improvements
Excellent communication and collaboration skills to work with cross-functional teams and external partners
Familiarity with Clinical Trial Agreements, site feasibility, and activation processes
Leadership and mentoring abilities to guide junior team members

Job Responsibility

Develop and oversee study quality-related plans, including Oversight Quality and Audit Plans
Collaborate with third parties to formalize Investigator Site Audits (ISA) and agendas
Oversee quality activities for phase 2-3 trials, focusing on risk management and endpoint de-risking
Conduct risk-based reviews of study documents to ensure compliance with protocols, ICH-GCP, and regulatory requirements
Act as the Clinical Quality Assurance Representative in weekly monitor-site meetings
Monitor site performance, ensuring adherence to monitoring plans, tracking deviations, and recommending improvements
Ensure internal operations align with study plans, SOPs, and maintain transparent communication regarding quality events
Maintain and update Clinical Trial Oversight Plans and Clinical Quality Plans
Ensure proper documentation and adherence to Clinical Trial Agreements, site feasibility, qualification, initiation, and activation processes
Collaborate with TMF managers to ensure the Trial Master File (TMF) remains accurate and inspection ready

Fulltime

Group Regulatory Affairs Specialist Class II

At Ontex, we are making everyday life easier across generations. Worldwide our 5...

Location

Germany , Grosspostwitz

Salary:

Not provided

Ontex Peninsular

Expiration Date

Until further notice

Requirements

Master’s degree (university or equal through experience) in science
In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
Minimum of 3 years experience in Regulatory Affairs for medical devices
Experience in 510k submission
Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
Experience in working with cross-functional teams and building strong relationships across departments
Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
Ability to lead, manage, collaborate and communicate within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession
Fluent in English

Job Responsibility

Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities
Monitor and evaluate the regulatory environment and provide creative and innovative internal advice throughout the product lifecycle
Supervises data input activities and provides impact analysis and report conclusions and recommendations
Identifies the need for new regulatory procedures and SOPs
Identifies requirements and potential obstacles for market access and distribution
Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
Actively contribute in assessing the potential impact of new guidance and regulations on a regulatory filing
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
Works with cross-functional teams for interactions with regulatory authorities
Provides regulatory information and guidance for proposed product claims/labelling

What we offer

Holiday and Christmas bonuses
30 days of holiday
Company pension scheme
Corporate benefits and discounts

Fulltime

Regulatory Affairs Specialist II

On behalf of our client, a leading manufacturer and seller of products for the l...

Location

United States , Irvine

Salary:

45.00 - 50.00 USD / Hour

Tucker Parker Smith Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Biochemistry, Biology, Medical Technology, or a related field
3–5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry
Knowledge of FDA and CE marking requirements for IVD products strongly preferred
Strong ability to work both independently and in a collaborative environment
Excellent communication skills, with the ability to negotiate and persuade effectively
Proven analytical, problem-solving, critical thinking, and computer skills
In-depth understanding of Regulatory Affairs policies, practices, and procedures

Job Responsibility

Revise assigned technical files using the latest templates to ensure clarity and compliance with IVDR requirements, including incorporation of technical reports, validations, and test data
Meet pre-defined timelines and actively participate in multiple weekly meetings to address issues, answer questions, and provide progress updates to the project manager
Support the IVDR labeling conversion project by updating specifications, tracking logs, and collaborating cross-functionally to ensure compliance
Monitor monthly manufacturing schedules, product fill dates, lot numbers, and change requests for accurate labeling updates
Manage un-CE Marking of selected products and track changes until final labeling reflects updated specifications
Maintain technical file tracking logs and notify regional RA teams of labeling changes
Coordinate with the RA SAP restriction coordinator to restrict specific product lots when required

Regulatory Affairs Specialist

An excellent opportunity to join a leading global food business based in central...

Location

United Kingdom , London

Salary:

45000.00 - 50000.00 GBP / Year

The People Co.

Expiration Date

Until further notice

Requirements

5+ years of technical or regulatory experience in food, feed or ingredients
Highly analytical, and organised with keen attention to
Must be able to identify problems and provide systematic
Be able to multi-task and have excellent communication skills
Real team player – Must be able to work with senior and junior employees in a professional and inclusive manner
A high level of business English is essential
The successful candidate will be self-motivated
Strong administration skills on Microsoft Office Packaging on Windows

Job Responsibility

Ensure regulatory compliance with food and feed safety, quality and defence as it relates to UK, EU and GFSI (BRC) requirements, Organic, Halal, FAMI QS and Kosher
Monitor changes in legislation and regulatory requirements, proactively assessing the impact on business and updating the senior management team's compliance protocols as necessary
Support the development and implementation of regulatory strategies for existing ingredients and new ingredients/products in the UK and EU regions ensuring compliance to but not limited to Allergens, REACH, Novel food, Packaging Food Contact Materials, Food Law and labelling, Feed laws and labelling, Residues and Contaminants, Natural and Botanical ingredients etc
Provide regulatory review of product compliance when an in-depth analysis/review is needed for the quality department. Example of review provided: Novel food status, specific application status, claims, labelling
Coordinate with authorities for all work required, such as authorisation and licenses
Support the design and maintenance of Prinova Specification, ensure all information is correct and meets relevant EU regulation requirements
Provide training for the quality and technical teams in Europe
Actively support QA department tasks according to workload and priorities, as required
Provide support to the commercial and marketing team to verify regulatory compliance
Assisting, as required, in the management of crises and incidents as part of the management team

Senior Process Quality Excellence Specialist

We are supporting a global pharma company who are seeking an experienced Senior ...

Location

United Kingdom , Slough

Salary:

40.00 - 47.00 GBP / Hour

SRG

Expiration Date

Until further notice

Requirements

8+ years' experience in the pharmaceutical industry, ideally within global Quality Assurance or Clinical Development
Strong expertise in GCP and GVP, with hands‑on experience in global audits and/or inspections
Minimum 2 years' experience writing or revising SOPs
Demonstrated ability to interpret regulatory guidance and coordinate SME engagement across functions
Excellent communication and stakeholder‑management skills, with experience supporting audits, inspection readiness, and CAPA follow‑up

Job Responsibility

Support the creation, revision, and implementation of GCSO quality and compliance policies, SOPs, and processes
Collaborate with Global Quality, Patient Safety, Regulatory Affairs, and external partners to ensure compliance with ICH GCP, GLP, PV and global/local regulations
Lead and drive inspection readiness activities across GCSO, serving as a central coordinator with inspection teams
Represent GCSO during internal and external audits/inspections, supporting preparation and follow‑up activities
Act as Regulatory Intelligence (RIN) Coordinator, reviewing regulations, identifying relevant SMEs, and ensuring CROs assess country‑specific regulatory impacts

Fulltime

Quality Assurance Regulatory Affairs Specialist

360 Resourcing Solutions

Location:
United Kingdom , Oxford

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 10, 2026

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