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

New

Senior International Tax Manager

We are seeking a highly motivated Senior International Tax Manager to strengthen...

Location

Spain , Madrid

Salary:

Not provided

Alter Domus

Expiration Date

Until further notice

Requirements

8–12 years of relevant experience, ideally gained in Big Four international tax teams and/or in house multinational groups
Specific experiences with overseeing multiples jurisdictions and coordinating global tax project within multiple jurisdictions
Strong knowledge of international corporate tax principles and cross border taxation
Proven experience managing multi jurisdictional tax matters through advisor networks
Exposure to reorganisations, group simplification, M&A, withholding tax, tax audits and governance frameworks
Familiarity with Pillar Two, DAC6, CbCR and global tax transparency initiatives
Strong analytical, project management and problem solving skills
Commercial mindset with the ability to balance technical accuracy and pragmatism
Fluent English required
other European languages advantageous

Job Responsibility

Lead and coordinate tax matters across the Group's international jurisdictions (excluding Luxembourg and the United States)
Oversee local tax compliance obligations through local finance teams and external advisors
Monitor tax filing calendars, tax payments, deadlines and recurring obligations across jurisdictions
Review local tax positions and ensure consistency with Group tax policies, governance standards and risk appetite
Coordinate tax input for new entity setups, closures, liquidations and structural changes
Maintain ongoing visibility over tax risks, exposures and planning opportunities across the international footprint
Own and drive tax workstreams relating to legal entity simplification projects, mergers, liquidations and internal reorganisations
Lead tax input on dividend repatriation strategies, withholding tax management and broader cash extraction initiatives
Assess tax implications of cross border financing flows and intercompany arrangements
Provide tax support on acquisitions, disposals and business expansion initiatives, as required

What we offer

Support for professional accreditations such as ACCA and study leave
Flexible arrangements, generous holidays, plus an additional day off for your birthday
Continuous mentoring along your career progression
Active sports, events and social committees across our offices
24/7 support available from our Employee Assistance Program
The opportunity to invest in our growth and success through our Employee Share Plan
Plus additional local benefits depending on your location

Fulltime

Senior Principal Electrical Engineer

The Senior Principal Electrical Engineer is tasked with solving unique and compl...

Location

India , Chennai

Salary:

Not provided

McDermott

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Engineering
15-20 years of experience in oil and gas with major contractors or consultants predominantly performing detail design
Recognized as having good communication and presentation skills
Detailed knowledge of design techniques and analysis methods, and detailed knowledge of the theory, content, and application of standards, codes, and guidelines as applicable
Knowledgeable in project coordination and execution skills
Recognized across the company as a key lead, highly innovative designer, or highly skilled analyst

Job Responsibility

Perform conceptual, FEED, and detailed analyses and design as per design basis, project specifications, design codes, and standards
Develop creative and innovative solutions that are reliable and cost-effective for problems and challenges when they arise
Apply expertise to the most complex problems
Manage own time to meet objectives and (as Lead Engineer) forecast and plan resource requirements
Develop and manage plans to achieve business objectives
Communicate and explain highly complex ideas and anticipate potential objections, influencing outcomes
When acting as Lead Engineer, in addition: Direct large Engineering team as a Lead Engineer
Lead the Discipline engineering design of the assigned work area and completed it within the planned schedule and budget, by standards, MDR, and project-specific procedures and to a high professional standard
Plan, organize, and direct all aspects of Discipline execution on the assigned project including scope, deliverables, schedule, and all manpower resources - agree allocations with the Discipline Manager
Ensure interfaces and deliverables are identified

Fulltime

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

Senior Principal HSE Engineer (Technical Safety & Loss Prevention)

The Senior Principal HSE Engineer (Technical Safety & Loss Prevention) is tasked...

Location

United Arab Emirates , Dubai

Salary:

Not provided

McDermott

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or Master’s Degree in Engineering
20+ years of experience in oil and gas of which preferably 15 years in offshore with major EPC contractors or consultants predominantly performing detail design
Preferably Registered Professional Engineer or member of professional engineering society as applicable
Detailed knowledge of safety studies, Loss prevention, design techniques and analysis methods especially for major large offshore projects
As a minimum good working knowledge on safety simulation tools such as PHAST, Flaresim, SAFETI, DETECT3 (preferable) and good understanding of CFD analysis
Knowledgeable in project coordination and execution skills
Recognized as having good communication and presentation skills
Demonstrated EPC Project Lead HSE Engineer experience

Job Responsibility

To be able to Lead Offshore large process intensive EPC Projects
Ensure timely delivery of deliverables with the required quality and within given schedule
Develop creative and innovative solutions that are reliable and cost-effective for problems and challenges when they arise
Apply expertise to the most complex problems
Review, and (as Lead Engineer) approve the following: Design HSE & fire protection philosophies, Safety study scope of work specifications, requisitions, TBE reports, Safety equipment lists, Firefighting equipment specifications and data sheets, Lifesaving and personnel safety equipment specifications and data sheets, Safety sign specifications and data sheets, Firewater demand and hydraulic calculation reports using PIPENET or equivalent software, Inputs to P&ID markups for Firewater ring main system and Deluge system including providing details of interconnection with hose reels, monitors, hydrants, and deluge valves /nozzles, Escape route and safety equipment layouts, Safety sign layouts, Third-party safety study reports that comply with project specifications
Participate and coordinate safety workshops (such as HAZID/HAZOP)
Review and approve safety study close-out reports
Review and approve FP&S and relevant other disciplines' vendor data
Review and approve technical notes on PFP rating requirements for the project based on Safety Study recommendations
Review and approve inputs for FP&S layouts, fire, and gas detection layouts, and cause and effect matrices

Fulltime

New

Senior Principal Construct Support Eng

The Senior Principal Engineering Spec is tasked with solving unique and complex ...

Location

United Kingdom , Chiswick, London

Salary:

Not provided

McDermott

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Naval Architecture, Civil/Structural/Mechanical Engineering (Master’s is a preference)
20+ years of experience in Oil and Gas with major contractors or consultants predominantly performing detail design
Detailed knowledge of design techniques and analysis methods and detailed knowledge of the theory, content, and application of standards, codes, and guidelines as applicable to offshore
Knowledgeable in project coordination and execution skills
Proficient in MS Office applications (Word, Excel, etc.)
Recognized across the company as a key lead, highly innovative designer, or highly skilled analyst
Preferably a Registered Professional Engineer or member of a professional engineering society
Recognized as having good communication and presentation skills (e.g., published technical papers are clearly written, actively participates in conferences or seminars, and/or is a capable presenter of design solutions or topics at MDR learning sessions)
Experience working with SURF Contractor is essential

Job Responsibility

Perform conceptual, FEED, and detailed analyses and design as per design basis, project specifications, design codes, and standards
Proven and long term experience in planning and preparing the Construction Support Engineering associated to SURF operation, including and not limited to seafastening engineering, temporary and permanent lifting arrangement and marine transportation at various design stages including: tendering and detailed/installation design stage
Develop creative and innovative solutions that are reliable and cost-effective for problems and challenges when they arise
Apply expertise to the most complex problems
Manage own time to meet objectives, and (as Lead Engineer) forecast and plan resource requirements
Develop and manage plans to achieve business objectives
Clearly communicate and explain highly complex ideas and anticipate potential objections, influencing outcomes
Become fully familiar with the project scope of work, specifications, schedule, and all inter-discipline requirements, including identifying concerns as early as practicable and taking appropriate initiatives to address issues, interpret contractual requirements as they relate to engineering execution
Identify changes to scope and promptly raise change notifications, including providing any necessary supporting documentation and estimates
Provide similar support for variation orders

Fulltime

New

Senior Expert Biocompatibility

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

Location

Germany; Italy , Bad Homburg; St. Wendel; Schweinfurt; Palazzo Pignano

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)
Highly Experienced in writing biocompatibility evaluations
Deep 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
Strong 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
Proven track record in project and/or test management

Job Responsibility

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)
Planning, interpretation and evaluation of analytical and biological tests performed by internal or external laboratories
Compilation of overall biological safety assessment according to ISO 10993-1
Derive 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
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

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

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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