Regulatory Affairs Specialist II

About Boston Scientific:Job Title: Regulatory Affairs Specialist II – NeuromodulationKey Responsibilities:Support regulatory submission activities for clinical investigations and product distributions globally.Ensure compliance with regulatory requirements worldwide.Key Accountabilities:Prepare submissions for worldwide product approvals.Support clinical...

About the Role:This is a critical position within Boston Scientific, responsible for supporting the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide.Your Key Responsibilities:Support the preparation of submissions (e.g., PMA, PMA supplements, CE...

About Abbott LaboratoriesAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people...

Position: Senior Quality/Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:As a Senior Quality/Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance and quality within the regulatory affairs sector. Your expertise will be essential in supporting the regulatory affairs team from a quality assurance and compliance...

About AbbottAbbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our diverse portfolio includes innovative technologies across diagnostics, medical devices, nutritionals, and branded generic medicines, supported by a workforce of 114,000 professionals in over 160...

About Abbott:Abbott is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their journey. Our extensive range of transformative technologies encompasses various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medications. With a workforce of...

About the RoleAbbott Laboratories, a global healthcare leader, is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will play a critical role in ensuring efficient and compliant business processes and environment.Key ResponsibilitiesStrategic Planning:Provide regulatory input to...

Lead Specialist in Regulatory AffairsAbbott stands as a prominent figure in the global healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses various healthcare domains, featuring top-tier businesses and products in diagnostics, medical devices,...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to lead our global regulatory strategies for transcatheter valve technologies at Medtronic. This role involves overseeing a team, collaborating with stakeholders, and ensuring compliance with regulatory requirements.Key Responsibilities:Develop and implement regulatory strategies for...

Regulatory Affairs SpecialistCompany: GForce Life SciencesEmployment Type: Full-time, 12-month contractOverview: GForce Life Sciences is seeking a dedicated regulatory affairs specialist. This role involves crafting and executing regulatory strategies in partnership with diverse stakeholders within the medical device sector.Primary Responsibilities:Develop...

Director, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Full-Time Role with Direct HireCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work SettingPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory...

Chief, CMC Regulatory Affairs - Pivotal Opportunity at Bayside Solutions, Inc.Full-Time Employment with Direct HireCompensation: Competitive salaryLocation: Dynamic Redwood City, CA - Hybrid Work EnvironmentPosition Overview:In the role of Chief of CMC Regulatory Affairs, you will be instrumental in formulating and executing regulatory strategies that...

Chief of CMC Regulatory Affairs - Pivotal Opportunity at Bayside Solutions, Inc.Position Type: Full-Time with Direct HireCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work SettingRole Overview:In the capacity of Chief of CMC Regulatory Affairs, you will be instrumental in crafting and executing regulatory frameworks that...

Chief, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Position Type: Full-Time with Direct HireCompensation: Competitive salary offeredLocation: Hybrid Work Environment in Redwood City, CAPosition Overview:In the role of Chief of CMC Regulatory Affairs, you will be instrumental in formulating and executing regulatory...

Director, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Full-Time Position with Direct HireCompensation: Competitive salaryLocation: Flexible Hybrid Work EnvironmentPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory frameworks that facilitate...

Director, CMC Regulatory Affairs - Key Leadership Position at Bayside Solutions, Inc.Full-Time Role with Direct Hire OpportunityCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work ModelPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory...

Job Summary:The position is responsible for providing strategic guidance on CMC regulatory matters and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.Key Responsibilities:Develop and implement CMC regulatory strategies to support the clinical...

Position Overview:We are seeking a highly skilled regulatory professional to join our Companion Diagnostics (CDx) team. The successful candidate will report to the Sr. Director of Regulatory Affairs (CDx) and must possess extensive global regulatory experience in In Vitro Diagnostics (IVD), Medical Devices, or Pharmaceuticals, with a proven track record of...

Position Overview:We are seeking a highly skilled regulatory professional to join our Companion Diagnostics (CDx) team. The successful candidate will report directly to the Sr. Director of Regulatory Affairs (CDx) and must possess extensive global regulatory experience in In Vitro Diagnostics (IVD), Medical Devices, or Pharmaceuticals. A proven track record...

Position: Regulatory Affairs Project ManagerCompany: Intellectt IncLocation: Santa Clara, CAJob Overview:Education: A Bachelor's degree is mandatory; a Master's degree is advantageous.Experience: At least 3 years of relevant experience is essential.Skills: Familiarity with US and/or Canadian regulations concerning product and/or device approval (FDA) is...