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Posted : Saturday, August 03, 2024 08:46 AM
Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.
From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services.
It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries.
Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.
72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description The regulatory affairs associate is responsible for supporting the biodevice, medical device, and diagnostic portfolio within global diagnostic animal health.
They will support US and international product registration requirements, as well as address product needs for emerging regulations related to animal health diagnostics.
This role will be responsible for coordinating and supporting activities to assure designated veterinary diagnostics, including biodevices and medical devices, are developed and licensed in compliance with client policies and appropriate regulatory requirements.
The employee will work with a team of 5-10 Diagnostics Regulatory Affairs colleagues and will support the following key areas: Product registrations, compiling regulatory documents and international product requirements, post-market change support support, and document maintenance within the client Enterprise-wide document control system.
The employee will work with the Global Diagnostics Regulatory Affairs Team and/or independently, based on the tasks, and will be a full time (40hr/week) position supporting the Veterinary Diagnostics Products.
Core Responsibilities include: Global Product Registration Support: Assure appropriate regulatory requirements are provided to support global registrations Collaborate with the cross functional development teams to ensure regulatory project needs are met Facilitate the registrations and global expansions of animal health diagnostic products Emerging Regulation Support: Coordinate with Regulatory Affairs Managers and Manufacturing Compliance Members to assess impact on diagnostic product for new/emerging regulations, as needed Perform impact assessments and gap analysis of projects, processes, or products for compliance to new / emerging regulations Create mitigation strategies and timely communicate impact to leadership of regulation impact Collaborate with business partner groups as appropriate and required Other specific duties and responsibilities as detailed in goals or agreed with line manager Qualifications Bachelors degree in relevant scientific field.
Candidates located within a commutable distance to Kalamazoo, MI are encouraged to apply.
Exposure to or experience with regulatory affairs Technical lab experience Documentation experience within lab setting Strong project management skills including stakeholder management.
Knowledge in the production and testing of biologic/IVD products desirable.
High level of competency using Microsoft Office suite – with demonstrated high level competence of working in Microsoft Word and Excel.
Must be able to effectively communicate in English with colleagues at all levels of the organization.
Additional Information Position is full-time, first shift.
Excellent full-time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays #LI-LW1 Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services.
It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries.
Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.
72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description The regulatory affairs associate is responsible for supporting the biodevice, medical device, and diagnostic portfolio within global diagnostic animal health.
They will support US and international product registration requirements, as well as address product needs for emerging regulations related to animal health diagnostics.
This role will be responsible for coordinating and supporting activities to assure designated veterinary diagnostics, including biodevices and medical devices, are developed and licensed in compliance with client policies and appropriate regulatory requirements.
The employee will work with a team of 5-10 Diagnostics Regulatory Affairs colleagues and will support the following key areas: Product registrations, compiling regulatory documents and international product requirements, post-market change support support, and document maintenance within the client Enterprise-wide document control system.
The employee will work with the Global Diagnostics Regulatory Affairs Team and/or independently, based on the tasks, and will be a full time (40hr/week) position supporting the Veterinary Diagnostics Products.
Core Responsibilities include: Global Product Registration Support: Assure appropriate regulatory requirements are provided to support global registrations Collaborate with the cross functional development teams to ensure regulatory project needs are met Facilitate the registrations and global expansions of animal health diagnostic products Emerging Regulation Support: Coordinate with Regulatory Affairs Managers and Manufacturing Compliance Members to assess impact on diagnostic product for new/emerging regulations, as needed Perform impact assessments and gap analysis of projects, processes, or products for compliance to new / emerging regulations Create mitigation strategies and timely communicate impact to leadership of regulation impact Collaborate with business partner groups as appropriate and required Other specific duties and responsibilities as detailed in goals or agreed with line manager Qualifications Bachelors degree in relevant scientific field.
Candidates located within a commutable distance to Kalamazoo, MI are encouraged to apply.
Exposure to or experience with regulatory affairs Technical lab experience Documentation experience within lab setting Strong project management skills including stakeholder management.
Knowledge in the production and testing of biologic/IVD products desirable.
High level of competency using Microsoft Office suite – with demonstrated high level competence of working in Microsoft Word and Excel.
Must be able to effectively communicate in English with colleagues at all levels of the organization.
Additional Information Position is full-time, first shift.
Excellent full-time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays #LI-LW1 Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
• Phone : NA
• Location : Kalamazoo, MI
• Post ID: 9006132500
