Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist to join our team in the Infectious Disease business unit.The successful candidate will be responsible for preparing documentation for EU Technical Files and international product registrations.This is an excellent opportunity for a skilled Regulatory Affairs professional to take their career to the next level...

Job DescriptionThis role is designed to support the regulatory department in ensuring efficient and compliant business processes and environment. As a Regulatory Affairs Specialist, you will execute tasks to evaluate product and software changes in consideration of regulatory guidance documents and regulations.Your responsibilities will include providing...

We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Collabera. As a key member of our Infectious Disease business unit, you will play a crucial role in preparing documentation for EU Technical Files and international product registrations.This is an exciting opportunity for a talented professional to develop their skills in...

Company OverviewAcro Service Corp is a dynamic and innovative organization that strives to deliver exceptional services in the pharmaceutical industry.We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member, you will play a crucial role in ensuring compliance with federal and international regulations, standards, and...

Regulatory Compliance Role:Synectics Inc seeks a talented and detail-oriented individual to fill the position of Commercial Compliance Analyst in our US Commercial Compliance department. This role offers a unique opportunity to make a significant impact on our company's regulatory compliance efforts and contribute to the growth and success of our...

About the RoleThe estimated salary for this position is $120,000 - $180,000 per annum.We are seeking a highly skilled Medical Affairs Manager to join our team at Collabera. The successful candidate will be responsible for defining medical affairs strategy and conducting medical activities related to the IVDR process.Key responsibilities include:Supporting...

We are seeking a highly skilled EU Regulatory Compliance Manager to join our team at Collabera. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with EU regulatory requirements for our Infectious Disease business unit.This is an exciting opportunity for a talented professional to develop their skills in...

About Our CompanyKyyba is a leading provider of high-quality resources and top-notch recruiting services. With a global presence and headquarters in Farmington Hills, MI, we enable businesses to effectively respond to organizational changes and technological advances. Our core values of value, passion, excellence, empowerment, and happiness create a vibrant...

About the RoleThis Regulatory Affairs Specialist position involves technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). You will provide regulatory support for diagnostic product development and commercial diagnostic products, developing regulatory strategies for products in development and for modified products...

About UsAbbott Laboratories is a global healthcare leader dedicated to helping people live more fully at all stages of life. Our diverse portfolio spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.We empower smarter medical and economic decision-making to help...

Collabera is seeking a highly motivated and experienced Technical Writing Expert to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing regulatory documents, including EU Technical Files and international product registrations.This is an excellent opportunity for a talented writer to leverage their...

About the RoleWe are looking for a skilled Clinical Research Associate to join our team in Lake Forest, IL.The successful candidate will be responsible for managing sites through the life of trial and close-out, ensuring compliance with applicable Corporate and Divisional Policies and Procedures.Key Responsibilities:Conduct site qualification and initiation...

Job OverviewThis HR Business Partner role is a key position within our organization, responsible for providing strategic HR leadership and coaching to managers and employees within the R&D, Regulatory, Medical/Scientific Affairs, and Quality functions in Transfusion Medicine. The successful candidate will be able to prioritize critical projects based on...

Key ResponsibilitiesThe successful candidate will be responsible for:Preparing documentation for EU Technical Files and international product registrationsProviding regulatory support for diagnostic product development and commercial diagnostic productsDeveloping regulatory strategies for products in development and for modified productsResearching and...

Job Description:The Administrative Support Specialist will provide administrative assistance to the Vice President of Global Policy & U.S. Access Strategies within Government Affairs department. This role involves managing calendars, coordinating travel, processing expense reports, organizing logistics for meetings and workshops, developing materials for...

We are seeking a highly motivated Compliance Officer II to join our team in the Infectious Disease business unit.The successful candidate will be responsible for ensuring compliance with regulatory requirements and developing regulatory strategies for products.Key Responsibilities:Analysis of regulatory requirements and development of compliance...

About the RoleWe are seeking a skilled Quality Assurance Specialist to join our team at Kyyba. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our medical devices and maintaining compliance with regulatory requirements.Key ResponsibilitiesEnter records in eQMS systems such as Isotrain, Trackwise, Veeva, Agile,...

About the RoleWe are seeking an experienced Administrative Assistant Professional to join our team at Collabera.In this role, you will provide critical administrative support to the Vice President of Global Policy & U.S. Access Strategies within Government Affairs department.Key FunctionsManage calendars, coordinate travel, and process expense...

About the RoleWe are seeking a highly skilled IT Auditor Specialist to join our team at Akorn, Inc. This is an exciting opportunity for a talented professional to leverage their expertise in IT audit and risk management to contribute to the success of our organization.The estimated salary for this role is $85,000 - $110,000 per year, depending on...

About the Role:The Medical Digital Health Lead, Sr. Director plays a pivotal role in closing care gaps through medical digital innovation within Global Medical Affairs.This individual manages the governance and process navigation of the Biopharma Medical Digital Health portfolio, collaborating with therapeutic areas, Global Digital, Legal / Compliance,...