Complaint Handling & Vigilance Manager Job at Medline Europe (Utrecht)

New

Manager Quality & Vigilance

As a Manager Quality & Vigilance (m/f/d), you will take on a key role within our...

Location

Germany , Kleve

Salary:

Not provided

Medline Europe

Expiration Date

Until further notice

Requirements

Degree in a scientific, technical, or medical field
Several years of experience in the medical device industry, ideally in Complaint Handling / Vigilance
Leadership experience, ideally across multiple locations
Strong knowledge of relevant regulations (e.g., ISO 13485, MDR 2017/745)
Structured, analytical mindset and strong problem-solving skills
Excellent communication skills and confidence in interacting with authorities
Fluent English

Job Responsibility

Lead, develop, and coach a team of Complaint & Vigilance Specialists
Own the end-to-end complaint handling process — from intake to evaluation and reporting
Ensure full compliance with all regulatory requirements (e.g., EU MDR)
Continuously improve processes, tools, and workflows
Collaborate closely with cross-functional stakeholders (QA, Regulatory, Clinical, Product Management)
Act as a key contact for authorities and support audits and inspections
Establish and monitor relevant KPIs to ensure transparency and high quality

What we offer

Flexible working arrangements
30 days of vacation
Company pension scheme
Additional benefits of an international company

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

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

Senior RA/QA Executive, APAC

Senior RA/QA Executive, APAC (m/f/d) at KARL STORZ. Job Function: Quality Manage...

Location

Singapore , Singapore

Salary:

Not provided

KARL STORZ

Expiration Date

Until further notice

Requirements

Recognised Diploma/Degree in Life Sciences, Engineering, Regulatory or related field
3-4 years of experience in RAQA within the medical device industry
Experience working in a regional or multi-country environment with cross-functional teams
Excellent organizational, analytical, and communication skills
Strong interpersonal and communication skills
Meticulous attention to details
Good time management skills are highly essential

Job Responsibility

Regulatory Submissions & Change Notification Governance: Coordinate and track timely submissions for product registrations, renewals, and variations across Asia. Own the end-to-end process for regulatory change notifications, ensuring impact assessments, documentation readiness, and submission tracking in partnership with country RAQA and global teams
Regulatory Intelligence, Labelling & UDI Compliance: With the support of local RAQA, monitor evolving Asia regulations and provide strategic insights on labelling and UDI requirements. Support impact assessments, update SOPs/templates, and disseminate regulatory intelligence to country teams to ensure compliance and traceability
Complaint Handling, FSCA & Recall Execution: Lead regional coordination of complaint intake, triage, and resolution. Manage FSCA and recall processes, ensuring timely execution, regulatory reporting, and effective field actions in collaboration with Quality, Supply Chain, and Commercial teams
Post-Market Surveillance (PMS) Strategy & Vigilance: Monitor and analyse PMS data trends to identify emerging risks. Lead regional input into global PMS reports, risk assessments, and vigilance submissions. Ensure compliance with local adverse event reporting and surveillance requirements
Data Management, Reporting & Transparency: Maintain dashboards and trackers for regulatory submissions, PMS, quality metrics, and compliance status across APAC markets. Provide regular reporting to regional and global stakeholders to support visibility and decision-making
Process Harmonization & Continuous Improvement: Drive harmonization of RA and PMS processes across Asia, aligning with global standards. Identify and implement process improvements to enhance efficiency, compliance, and visibility. Develop SOPs, templates, and governance tools to support consistent execution
Training, Capability Building: Develop and deliver training programs on regulatory change, vigilance, and PMS processes. Act as a regional resource for country RAQA teams, providing coaching and escalation support
Ad-Hoc Regional Support & Escalations: Serve as a flexible point of contact for subsidiary-level needs intersecting with regional objectives. Provide timely assistance for emerging projects, pilot programs, authority inquiries, and urgent compliance matters as directed by the Regional RAQA Director or global RAQA teams

What we offer

Leave Benefits (Vacation Leave, Sick Leave, Parental Leave, etc.)
Birthday Benefits
Transport Allowance (if applicable to role)
Accessibility to Public Transport
Flexible Work Arrangements
Group Health Insurances
Flexi-Benefit Reimbursement
Wellness Programs and Activities
Professional Development Opportunities
Global Exposure & Business Travel Opportunities (if applicable to role)

Fulltime

Retail and forecourt assistant

Join our team for this new location, and become part of Supermac’s and the Plaza...

Location

Ireland , Ennis

Salary:

Not provided

Supermacs

Expiration Date

Until further notice

Requirements

Due to the sale of alcohol, candidates must be over 18
Previous experience is preferred
The ability to follow instructions – learn new skills
A friendly, professional manner
Demonstrates: Strong people skills
Above-average listening skills, organization, and planning skills
Excellent interpersonal skills
Attention to detail
Good work ethic
Good attitude towards customers and fellow workers

Job Responsibility

To serve customers in a friendly and efficient manner, providing an exceptional standard of customer care
To communicate with the customers in an effective and welcoming manner
To deal with customer complaints professionally and pleasant,y and refer to the store manager where appropriate
To accurately compute sales prices, total purchases, and receive & process appropriate payment from the customers in line with the cash register and/or cash handling policy
To follow company policies and procedures
Assist customers in bagging purchases
Maintain knowledge of current in-store sales and promotions
Answer customer queries about the store and its merchandise
Open and close cash registers, performing tasks such as counting money, balancing cash drawers, and making deposits in line with the cash handling policy
Clean shelves & counters and sweep floors internally and externally,y ensuring the store is tidy and free from clutter at all times

Fulltime

New

Quality Systems Manager

Location

United States , Burnsville

Salary:

130000.00 - 165000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in a scientific discipline or equivalent education/training
10+ years’ experience in Quality Systems
4+ years within the medical device industry
Comprehensive working knowledge of EU MDR, ISO 13485, 21 CFR 820
Experience leading audits, CAPA systems, and regulatory inspections
Proven ability to effectively influence cross-functional teams

Job Responsibility

Owns, maintains, and improves the Quality Management System in compliance with 21 CFR Part 820, EU MDR, ISO 13485, and other applicable international regulations and guidelines
Ensures effective implementation and ongoing compliance with QMS processes, procedures, and records
Owns and maintains electronic QMS system
Manages document control, record retention, and change control processes
Drives harmonization and simplification of quality documentation where possible
Owns and maintains external document and standards database and drive updates, as applicable
Plans, conducts, and manages internal audits and support external regulatory and customer audits
Acts as the primary interface with regulatory authorities and notified bodies during inspections
Leads audit responses, root cause analysis, and corrective actions to closure
Oversees the Corrective and Preventive Action (CAPA) system, ensuring timely, effective investigations and actions

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Customer Service Representative

The Customer Service Representative provides effective customer service for all ...

Location

United States , Kent, WA

Salary:

44200.00 - 60320.00 USD / Year

ASC Engineered Solutions

Expiration Date

Until further notice

Requirements

Associates' Degree in Business and/or Related Field
2 + years of Customer Service experience in the manufacturing or construction industry
Strong communication and interpersonal skills
Outstanding customer service skills
Excellent time management ability
Ability to handle adversity and conflict with successful outcomes
Outstanding attention to detail and accuracy
Possess strong commitment to team environment while working well with others
Work systematically and logically to resolve problems
Understanding of common business practices relating to pricing, terms, shipment, taxes and payment for products and services

Job Responsibility

Responsible for communicating with customers via phone, email, fax, etc.
Provide timely and accurate information to incoming customer service orders, status, and product knowledge request
Process customer orders, changes, and returns
Resolve customer complaints by investigating problems, developing solutions, and making recommendations
Work closely with the Operations Supervisor as directed
Review and maintain customer database to track information on account information, statuses, orders, and lead times
Provide timely feedback regarding service failures or customer concerns
Work closely with Sales Representatives on quotes, status of orders etc.
Promote a safe workplace by performing all tasks in a safe and thoughtful manner in compliance with all rules, procedures, instructions, devices, equipment and use of appropriate personal protective equipment. Maintain vigilance for any hazardous conditions or practices in the workplace and immediately report any unsafe conditions or practice to your supervisor
Perform other duties as directed

What we offer

Medical, Dental, Vision, and FSA are available 30 days following your start date
401k with company match is available after 90 days of employment
Company-provided Life Insurance and AD&D are provided 1st of the month after 90 days of employment at no cost to you
5 PTO days after 60 days of employment (hourly and non-exempt positions only)
2 weeks of vacation after 6 months of employment
10 paid holidays - including your birthday

Fulltime

New

Post Market Surveillance Analyst

The Post Market Specialist – Data Analyst supports post-market surveillance (PMS...

Location

United States , Alpharetta

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Statistics, Data Analytics, or related discipline)
2–5 years of experience in medical device, pharmaceutical, or regulated industry (preferred)
Experience with post-market surveillance, complaint handling, or regulatory reporting is highly desirable
Strong data analysis skills (e.g., Excel, statistical tools, or data visualization platforms such as Power BI, Tableau)
Ability to work at least three days per week (Tuesday – Thursday) in the office located in Alpharetta

Job Responsibility

Compile, analyze, and trend post-market data from multiple sources (e.g., complaints, adverse events, vigilance reports, literature, and regulatory databases)
Support the preparation of PMS reports, PSURs, and other regulatory-required documentation in accordance with global regulations (e.g., EU MDR, FDA, Health Canada)
Support the identification and analysis of emerging trends related to product safety, field actions, recalls, and regulatory enforcement (e.g., warning letters, recalls, safety alerts)
Perform statistical and qualitative analyses to detect safety signals and support risk management activities
Assist in the development and maintenance of dashboards and reporting tools for ongoing monitoring of product performance
Support recall and field action activities, including data collection, impact assessment, and reporting
Ensure data integrity, accuracy, and compliance with internal procedures and regulatory requirements
Assists with the investigation and documentation of low-risk customer complaints
Support audits and inspections by providing relevant data and documentation

What we offer

401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria
HQ region voted 'best place to live' by USA Today
uncapped sales commissions

Fulltime

Select Country

Complaint Handling & Vigilance Manager

Job Responsibility

Requirements

What we offer

Looking for more opportunities?