Manager Quality & Vigilance Job at Medline Europe (Kleve)

RA Manager

Eitan Medical is a fast-growing global medical device company, developing and ma...

Location

Israel , Netanya

Salary:

Not provided

Eitan Medical

Expiration Date

Until further notice

Requirements

BSc in a scientific area, (Bio-medical or Quality Engineering - an advantage) or acknowledged regulatory course graduate
2-4 years medical device/pharmaceutical post market experience
Knowledge and experience with the following regulatory systems: EU / Canada /US - advantage to other regulation
Minimum 2 years management experience
Strong verbal and written communication skills
Good technology expertise is essential
Experience in front of the authorized authorities
Understanding of risk management disciplines
English – very high level, verbal and written
Ability to work under pressure and in tight schedules

Job Responsibility

Managing the post market RA team
Support design and post market compliance of products from a regulatory perspective
Handling Vigilance, MDR and authorities’ inquiries of complaints
Support the investigation process from a regulatory perspective
Responsible for managing product field action
Responsible on regulatory assessment related QMS process
Responsible of company’s PSUR

Fulltime

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion. Manages the batch review and release activities
Fulfills the role of PRRC, specific to: Ensuring conformity of the devices is appropriately checked, in accordance with the Quality Management System, before release
Ensuring Post-Market Surveillance (PMS) obligations are met
Ensuring reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)
Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies
Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements
Understands and deploys processes to assure conformance to regulations in a mid-to-large plant or a large program or department. Manage regulatory inspections
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
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

Fulltime

Senior QA/RA Specialist

The primary role of Quality Assurance function is to ensure that management syst...

Location

United Kingdom; Ireland , Harrogate; Dublin

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

Bachelor's degree (technical or software background preferred) from four year college or university
at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
four (4) to five (5) years related experience or equivalent education and experience
Strong experience or exposure across Quality Systems (ISO 13485) / Design and Development of Medical device software (IEC 62304 environment)/ Supplier quality / Medical Device Regulation (MDR 2017/745)
Good Knowledge of ISO 13485 standard and Medical Device Regulation (MDR 2017/745)
Ability to exercise judgment
Good communication, planning and organizational skills
Proactive
able to provide initiative, ownership while working through uncertainty
Self-starter, with the ability to work with minimal supervision and with a sense of urgency

Job Responsibility

Role of Management Representative (ISO 13485)
Ensure the processes needed for the Quality Management System are effectively defined, documented, implemented and maintained
communicate and report on the performance and effectiveness of the QMS and any need for improvement to the senior management team and all other company personnel
Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
Coordinate and execute to support QMS activities
Ensure complaint handling / investigations, CAPA, Nonconformities, are processed and resolved in a timely manner
Suppliers’ management (including evaluation, monitoring, quality agreements)
Design and Development activities
Change control
Internal / external / supplier audits

What we offer

All employees benefit from a bonus plan
Working from home flexibility
Access to a referral bonus
Access to ResMed's preferred shareholding programme
Internal career opportunity

Fulltime

Case specialist

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Doctor in Pharmacy/Pharmacist by training
4-5 years of experience in a similar position
Database experience preferred
Knowledge of current regulations
Process oriented
Rigorous and ability to work in a team
Use of Microsoft Office tools
Ability to multitask
Flexibility
Excellent communication skills

Job Responsibility

Responsible for the Quality control of vigilance cases
Medical evaluation of reports
Data entry of vigilance cases in ad hoc databases or in other formats agreed with the client
Follow-up request of vigilance cases by phone/mail
Pre-analysis of complex cases prior to data entry
Medical evaluation of files on: Coding (according to applicable dictionary)
Causal relationship between the effects and the intake of suspect products (according to applicable method)
The expected/listed or unlisted nature of the events/effects/incidents
The seriousness of the events/effects/incidents and the case
Identification of submission requirements for each case

Fulltime

Combination Product Quality Specialist Consultant

We are seeking an experienced Combination Product Quality Specialist to support ...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Prior management consultancy experience is highly desirable
A degree in life sciences, pharmacy, engineering, or a related discipline
Significant experience (typically 8+ years) within combination products, pharmaceuticals, medical devices or biotechnology
Strong, hands‑on knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, EU MDR)
Proven experience authoring and maintaining quality and technical documentation in regulated environments
A well‑developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering
Experience with supplier quality, audits, CAPA and document control
Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders

Job Responsibility

Working within and advising on Quality Management Systems compliant with ISO 13485, QMSR, 21 CFR Part 4 and relevant GxP requirements
Authoring, reviewing and maintaining Design History Files, risk management files, technical documentation and change control records
Supporting supplier qualification, audits and gap assessments
Acting as a subject matter expert on drug–device interactions and product integrity considerations
Interpreting and overseeing Container Closure Integrity Testing (CCIT)
Supporting the design and evaluation of stability and compatibility studies
Interpreting and applying evolving global combination product regulations
Supporting the preparation of regulatory submissions, technical dossiers and responses
Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments
Contributing to process validation, equipment qualification and technical knowledge transfer

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

Case Specialist – Vigilance / Case Management

Deliver Excellence in Vigilance Case Management. Join our Case Management team a...

Location

Philippines

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in life sciences (e.g. pharmacy, medicine, nursing, dentistry) or equivalent experience in a vigilance environment
3 to 6 years of experience in pharmacovigilance or a related vigilance discipline
Strong knowledge of vigilance regulations and end‑to‑end case management activities, including QC and medical review
Excellent analytical skills, attention to detail, and ability to meet regulatory deadlines in a client‑focused environment
Strong communication skills and ability to collaborate effectively with clients and internal stakeholders

Job Responsibility

Ensure the accurate and compliant management of vigilance cases, acting as the guarantor of case quality from both a regulatory and medical perspective
Perform quality control (QC) and medical review of cases, including coding (e.g. MedDRA/IMDRF), seriousness, expectedness/listedness, and causality assessment
Validate case documentation, support data entry activities, and ensure timely follow‑up and reconciliation in client or internal safety databases
Analyze complex cases, including pre‑analysis prior to data entry, and provide medical or pharmaceutical input as required
Contribute to client and process monitoring activities, including participation in client onboarding, procedure drafting, and continuous process improvement initiatives

What we offer

Work with a diverse range of clients across medicines, vaccines, and medical devices, expanding your technical expertise and making a meaningful impact in Patient Safety across multiple therapeutic areas
Apply your scientific expertise to real‑world patient safety activities
Join a company that values expertise, excellence, collaboration and continuous improvement

Fulltime

Combination Product Quality Specialist Consultant

We believe in the power of ingenuity to build a positive human future. As strate...

Location

United Kingdom , Melbourn

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Prior management consultancy experience is highly desirable
A degree in life sciences, pharmacy, engineering, or a related discipline
Significant experience (typically 8+ years) within combination products, pharmaceuticals, medical devices or biotechnology
Strong, hands‑on knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, EU MDR)
Proven experience authoring and maintaining quality and technical documentation in regulated environments
A well‑developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering
Experience with supplier quality, audits, CAPA and document control
Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders

Job Responsibility

Working within and advising on Quality Management Systems compliant with ISO 13485, QMSR, 21 CFR Part 4 and relevant GxP requirements
Authoring, reviewing and maintaining Design History Files, risk management files, technical documentation and change control records, ensuring alignment and traceability across the product life cycle
Supporting supplier qualification, audits and gap assessments, ensuring compliance with global regulatory expectations
Acting as a subject matter expert on drug‑device interactions and product integrity considerations
Interpreting and overseeing Container Closure Integrity Testing (CCIT) to support sterility and product stability
Supporting the design and evaluation of stability and compatibility studies, considering both device and pharmaceutical components under real‑world conditions
Interpreting and applying evolving global combination product regulations, providing pragmatic guidance throughout development, technical transfer, commercialisation and post‑market phases
Supporting the preparation of regulatory submissions, technical dossiers and responses to questions from competent authorities and notified bodies
Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments
Contributing to process validation, equipment qualification and technical knowledge transfer, ensuring regulatory alignment throughout

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity‑based initiatives
Annual performance‑based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

Case Specialist

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Doctor in Pharmacy/Pharmacist by training
4-5 years of experience in a similar position
Database experience preferred
Knowledge of current regulations
Process oriented
Rigorous and ability to work in a team
Use of Microsoft Office tools
Ability to multitask
Flexibility
Excellent communication skills

Job Responsibility

Responsible for the Quality control of vigilance cases
Medical evaluation of reports
Data entry of vigilance cases in ad hoc databases or in other formats agreed with the client
Follow-up request of vigilance cases by phone/mail
Pre-analysis of complex cases prior to data entry
Medical evaluation of files on: Coding (according to applicable dictionary), Causal relationship between the effects and the intake of suspect products (according to applicable method), The expected/listed or unlisted nature of the events/effects/incidents, The seriousness of the events/effects/incidents and the case
Identification of submission requirements for each case
Validation of certain documents produced by the Data Manager/ Vigilance Associate / documentalist (phone call forms, etc)
Closing of vigilance files
Identification of requirements and applicable changes to set up ICSR/MLM filters

Fulltime

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Manager Quality & Vigilance

Job Description

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