Global MDR Coordinator Job at MillenniumSoft Inc (Covington)

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

New

Local Study Associate Director

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Five years of US focused clinical trial management experience, including budget oversight
Good knowledge of international guidelines ICH- GCP as well as relevant local regulations
Excellent project management skill
Excellent team building and interpersonal skills
Excellent organisational skills
Excellent verbal and written communication skills
Excellent ability to prioritize and handle multiple tasks
Excellent attention to details
Excellent knowledge of spoken and written English

Job Responsibility

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study
Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

New

Customer Service Representative

We want you to join our team as a Customer Service Representative. If you have t...

Location

United States of America , Dublin

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Retail and customer service experience
Sales associate or cashiering experience
High school diploma or equivalent
Motivation to advance in your career
Willingness to learn and have fun
Ability to stand and/or walk for up to 8 hours
Lift and/or carry up to 30 pounds from ground to overhead up to 30 minutes in a shift
Occasionally lift and/or carry up to 60 pounds from ground to waist level
Push/pull with arms up to a force of 20 pounds
Bend at the waist with some twisting up to one hour a shift

Job Responsibility

Greet customers
Run the register
Cashier
Make purchase suggestions
Sometimes work with our food program
Work around the store (inside and out) in many different areas to help maintain our high standards for store appearance
Provide fast and friendly service to our customers
Provide regular and predicable onsite attendance
Interact with many customers daily
Work with a fun, energetic team accomplishing daily tasks around the store

What we offer

Medical, Vision, Dental, & Life Insurance/Short & Long Term Disability
Flexible Schedules
Weekly Pay
Weekly Bonus Potential
Large, Stable Employer
Fast Career Opportunities
Work With Fun, Motivated People
Task Variety
Paid Comprehensive Training
401K With a Competitive Company Match

New

Store Manager

We are on the lookout for a management superstar, to support and motivate the te...

Location

Australia , Mandurah

Salary:

Not provided

Lowes Manhattan PTY LTD

Expiration Date

February 13, 2026

Requirements

Strong training and coaching abilities/experience
Previous experience in leading a team to success
Excellent communication and well-developed interpersonal skills
A desire to challenge yourself to achieve company objectives
Experience managing high volumes of stock
Excellent time management
Previous retail experience would be advantageous

Job Responsibility

Build and motivate a high-performing team
Ensure an exceptional customer experience is delivered
Manage the day-to-day running of the store
Assist with the achievement of sales, wages, and shrinkage budgets

What we offer

Ongoing development
Competitive salary package including penalty rates and opportunities for bonuses
Work/life balance
Extremely favourable staff discount
Supportive environment with ongoing recognition and support

Fulltime

New

Clinical Study Coordinator

Clinical Study Coordinator - Full Time, Benefits - Salt Lake City, Utah (UT). IC...

Location

United States , Salt Lake City

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline
Proven experience as a Clinical Study Coordinator or in a similar role
Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
Strong organizational and multitasking skills
Excellent communication and interpersonal abilities

Job Responsibility

Collaborating with cross-functional teams to develop and implement clinical trial protocols
Coordinating and overseeing the execution of clinical studies, ensuring adherence to protocols and regulatory requirements
Managing study timelines, budgets, and resources effectively
Facilitating communication between investigative sites, sponsors, and internal teams
Ensuring data accuracy and completeness through regular monitoring and quality control activities

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

New

Subway Sandwich Artist

The position includes, but is not limited to, the following essential job duties...

Location

United States of America , Houston

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

New

Sales Assistant

We are currently looking for a part-time (approx. 50 hours per fortnight) Sales ...

Location

Australia , Rouse Hill

Salary:

Not provided

Lowes Manhattan PTY LTD

Expiration Date

February 13, 2026

Requirements

Previous customer service experience
Excellent communication and interpersonal skills
Collaborative team player
A desire to challenge yourself to achieve company objectives
Flexibility to work a variety of weekday and weekend shifts

Job Responsibility

Deliver an exceptional customer experience
Support all elements of store operations including processing transactions, visual merchandising, stock replenishment/deliveries
Demonstrate strong product knowledge to assist customers
Work within a fun, close knit team environment to ensure the stores success

What we offer

Ongoing development - ongoing training, support and growth opportunities
Competitive pay rate - including penalties & overtime
Work/life balance - with a strong culture inspired by family values, we focus on work/life balance
Discounts - an extremely favourable staff discount

Parttime

Global MDR Coordinator

MillenniumSoft Inc

Location:
United States , Covington

Category:
Logistics

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 11, 2026

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Non-Pharma Global Regulatory Affairs Manager