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

Expert Biocompatibility

At Fresenius Medical Care, we are the global leader in kidney care, committed to...

Location

Germany , St. Wendel; Bad Homburg; Schweinfurt

Salary:

Not provided

FMS USA Fresenius Mgmt Services Inc

Expiration Date

Until further notice

Requirements

Successfully completed bachelor’s or master’s degree in scientific or engineering or a similar technical field required, such as medical technology
Related working experience: first years to 5 years, depending on level (Junior Expert / Expert)
First experience in writing biocompatibility evaluations
Knowledge with biocompatibility-testing and evaluations of medical devices according to ISO 10993
Application of Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO 13485, and ISO 14971
Knowledge with medical device risk management process and related regulations
Experience with product or design and development or quality engineering of sterile disposables utilizing various plastic processes such as injection molding and extruding
Ability to communicate technical information to non-technical audiences
Familiar with agile methodology
First Experience with ALM and PDM systems

Job Responsibility

Support Performance of safety and risk assessments for medical devices based on the used raw materials, on extractable and leachable chemicals or on biocompatibility studies (ISO 10993 series)
Drive planning, interpretation and evaluation of analytical and biological tests performed by internal or external laboratories under supervision of experienced team members
Assist in compilation of overall biological safety assessment according to ISO 10993-1
Support in deriving biocompatibility strategy details including material characterization, sampling of different product groups during new product developments or material/product changes
Acting as sponsor, study monitor and contact for chemical/ biocompatibility studies in internal and external laboratories
Ensure sufficient support of biocompatibility projects and coordinate how to apply overarching strategies
Align sampling and testing strategies and support product responsibles how to apply these
Coordinate global alignment of laboratory partners (internal and external) as well as methods applied
Overall responsibility for the assigned product groups and related biocompatibility files
Contribute to supplier agreements and specifications for biocompatibility requirements as well as material selection

What we offer

Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company

Fulltime

Senior Project Manager R&D

The Senior Project Manager – Surgical Tools and Technologies leads complex, cros...

Location

United States , Deerfield

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations

Job Responsibility

Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development

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 Project Manager R&D

The Senior Project Manager – Surgical Tools and Technologies leads complex, cros...

Location

United States , Deerfield

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations

Job Responsibility

Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development

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 Project Manager R&D

The Senior Project Manager – Surgical Tools and Technologies leads complex, cros...

Location

United States , Deerfield

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations

Job Responsibility

Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development

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

Toxicological Expert

At Fresenius Medical Care, we are the global leader in kidney care, committed to...

Location

Germany , St. Wendel; Bad Homburg

Salary:

Not provided

FMS USA Fresenius Mgmt Services Inc

Expiration Date

Until further notice

Requirements

Successfully completed master’s degree in scientific or engineering or a similar technical field required, such as medical technology
Related working experience: 2–8 years, depending on level (Expert / Senior Expert)
Advanced training in toxicology, e.g., avocational studies, trainings, etc.
Certification as toxicologist or started education highly welcome, e.g., European Registered Toxicologist (ERT) or Board Certified Toxicologist (DABT)
Deep knowledge of ISO 10993 standard series including respective trainings
Significant experience in chemical-analytical as well as biological biocompatibility testing as well as evaluations

Job Responsibility

Derive strategy for toxicological evaluations and risk assessment acc. ISO 10993-17 for different product groups and therapies
Support biocompatibility strategy details including material characterization, sampling of different product groups, chemical-analytical and biological testing as well as overall evaluation
Analyze results of chemical-analytical and biological testing for their toxicological profiles
Create toxicological risk assessments for leachables and extractables studies for all relevant products
Perform toxicological evaluations of substances or if needed assignment of mandates for external toxicologists and review of respective assessments
Support and coordinate with projects and product responsibles how to interpret the findings and measures to be taken, e.g., change of materials or production processes, measures to minimize leachables, etc.
Revise existing toxicological risk evaluations or reports for substances to comply with state-of-the-art data
Drive the global exchange and knowledge increase wrt toxicological evaluation of relevant substance groups and respective measures
Support with toxicological expert know-how and contribute to the overall biocompatibility reports for the products

What we offer

Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company

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

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Global MDR Coordinator

Non-Pharma Global Regulatory Affairs Manager