We have other current jobs related to this field that you can find below
-
Regulatory Affairs Specialist
3 months ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...
-
Regulatory Affairs Specialist
3 months ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...
-
Santa Clara, California, United States Intellectt Inc Full timePosition: 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...
-
Regulatory Affairs Senior Specialist
3 days ago
Santa Clara, California, United States Abbott Full timeAbout 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...
-
Senior Regulatory Affairs Associate II
2 days ago
Santa Clara, California, United States Abbott Full timeAbout 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...
-
Regulatory Affairs Specialist II
2 months ago
Santa Clarita, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Regulatory Affairs Specialist II – Neuromodulation About the role:Support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory...
-
Regulatory Affairs Specialist
4 weeks ago
Santa Clara, United States Abbott Laboratories Full timeAbbott 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 in more than 160 countries.About...
-
Santa Clara, United States Abbott Laboratories Full timeAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life....
-
Lead Specialist in Regulatory Affairs
3 days ago
Santa Clara, California, United States Abbott Full timeLead 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,...
-
Senior Regulatory Affairs Specialist
3 months ago
Santa Clara, United States Abbott Laboratories Full timeAbbott 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 in more than 160 countries.Working at...
-
Regulatory Compliance Specialist
2 days ago
Santa Clara, California, United States GForce Life Sciences Full timeRegulatory 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...
-
Head of CMC Regulatory Affairs
3 days ago
Santa Clara, California, United States Bayside Solutions Full timeChief, 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...
-
Senior Regulatory Affairs Consultant
2 days ago
Santa Clara, California, United States Direct Staffing Inc Full timePosition 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...
-
Principal Regulatory Affairs Specialist
1 week ago
Santa Clarita, United States huMannity Medtec Full timeAt HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...
-
Principal Regulatory Affairs Specialist
7 days ago
Santa Clarita, United States huMannity Medtec Full timeAt HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...
-
Senior Regulatory Affairs Consultant
2 days ago
Santa Clara, California, United States Direct Staffing Inc Full timePosition 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...
-
Regulatory Affairs Project Manager
3 days ago
Santa Clara, California, United States Intellectt Inc Full timePosition: 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...
-
Regulatory Specialist II
2 days ago
Santa Clara, United States Collabera Full time $35 - $40Job DescriptionJob Description· Must have 3-5 years of experiences in Medical Device Regulatory Affairs Skills.· Have working knowledge in EU MDR.· Have working knowledge in Regulatory Change Assessment in Have working knowledge in US and EU medical device submissions.· Have experience...
-
Regulatory Specialist II
3 months ago
Santa Clara, United States Collabera Full timeJob DescriptionJob Description· Must have 3-5 years of experiences in Medical Device Regulatory Affairs Skills.· Have working knowledge in EU MDR.· Have working knowledge in Regulatory Change Assessment in Have working knowledge in US and EU medical device submissions.· Have experience...
-
Regulatory Affairs, CMC Consultant
2 weeks ago
Santa Clara, United States Bayside Solutions Full timeRegulatory Affairs, CMC ConsultantW2 ContractLocation: Redwood City, CA - Hybrid or Remote PSTJob Summary:In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and...
Regulatory Affairs Specialist II
2 months ago
The Opportunity
We are recruiting for a
Regulatory Affairs Specialist II
to join our team on-site in Santa Clara, CA. This new team member will support manufacturing/operations day-to-day activities for change control and provide regulatory direction on team activities. The individual will apply basic regulatory understanding to support product and teams as well as prepare US/CE regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Additionally, they will handle regulatory activities involved in documentation, labeling, field support, and apply regulatory and technical knowledge to a focused area of work assignments. This Specialist understands, implements, and maintains the quality policy and ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
What You'll Work On
Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance, project plans.
Implements Division Regulatory Strategy in specific product-related activities.
Basic understanding of laws and regulations.
Obtains supervisory input for interpretation leading to the solution of issues, and to product development and support.
Analyzes the input of cumulative product changes to current product submissions.
Shares knowledge with others in the department and on teams.
Provides solutions to a variety of problems where analysis requires a moderate degree of evaluation.
Prepares and aligns individual goals with department goals.
Establishes and executes against project goals and implements plans.
Provides input to establishing group plans and implementation of those plans.
Follows GMP guidelines and procedures.
Writes effectively: Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences.
Responsible for implementing and maintaining the effectiveness of the quality system.
For products division-wide: Advises and communicates to the project, group, or venture regarding basic regulatory strategies.
Signs-off at the team level within delegated parameters for change control.
Release authority for labeling/sales/promotional materials.
Official correspondence with outside regulatory agencies is guided by supervisory staff.
Conducts basic negotiations on routine product-related issues with government agencies.
Follows through on submission-related activities to secure product approval.
Directs own daily activities by utilizing team goals and division regulatory priorities.
Provides support to Regulatory Affairs management when working towards the resolution of compliance issues, assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
Obtains supervisory regulatory review on submission documents prior to submission to government agencies.
Required Qualifications
Bachelor’s Degree or an equivalent combination of education and experience
5 years’ work experience
Preferred Qualifications
Bachelor’s degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, etc.
5+ years’ experience in the Medical Device industry
1-2 years of regulatory experience.
Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing.
Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
Think analytically with good problem-solving skills.
510(k), PMA, or other international regulatory submission experience.
RAPS Certification.
#J-18808-Ljbffr
