Current jobs related to Regulatory Affairs Project Manager - Santa Clara - GForce Life Sciences

  • Regulatory Affairs Project Manager

    4 weeks ago

    Santa Clara, California, United States Tek Support Full time

    Regulatory Affairs Project ManagerWe are seeking a highly skilled Regulatory Affairs Project Manager to oversee and coordinate regulatory activities for our medical devices. The ideal candidate will have a strong background in regulatory affairs and experience with US and international medical device regulations.Key Responsibilities:Develop and implement...

  • Regulatory Affairs Project Manager

    7 days ago

    Santa Clara, California, United States Collabera Full time

    Job Summary:Collabera is seeking a highly skilled Regulatory Affairs Project Leader to join our team. As a key member of our regulatory team, you will be responsible for managing and tracking broad and strategic projects, communicating effectively in writing crisp briefings and issue analysis, and demonstrating ability to work effectively in a team...

  • Regulatory Affairs Project Manager

    4 weeks ago

    Santa Clara, California, United States Intellectt Inc Full time

    Regulatory Affairs Project ManagerAt Intellectt Inc, we are seeking a highly skilled Regulatory Affairs Project Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Support IVDR compliance activities, including creation of...

  • Regulatory Affairs Project Manager

    4 weeks ago

    Santa Clara, California, United States Experis Full time

    Regulatory Affairs Project Manager Job DescriptionExperis IT ManpowerGroup is partnering with a leading Medical device organization in the Santa Clara area to fill a Regulatory Affairs Project Manager role. This is an on-site position.Job Responsibilities:Support IVDR compliance activities, including creation of technical files and post-market surveillance...

  • Regulatory Affairs Project Manager

    2 days ago

    Santa Clara, California, United States Collabera Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Project Leader to join our team at Collabera. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Assist in the development and implementation of regulatory strategies and...

  • Regulatory Affairs Project Manager

    2 weeks ago

    Santa Clara, California, United States Collabera Full time

    Job OverviewCollabera is seeking a highly skilled Regulatory Affairs Project Leader to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve business objectives.Key ResponsibilitiesDevelop and implement regulatory strategies to support business...

  • Regulatory Affairs Project Manager

    4 weeks ago

    Santa Clara, California, United States The Fountain Group Full time

    Regulatory Affairs Project ManagerWe are seeking a highly skilled Regulatory Affairs Project Manager to join our team at The Fountain Group. In this role, you will be responsible for coordinating and planning regulatory strategies and submissions to the FDA and other worldwide regulatory agencies.Key Responsibilities:Coordinate and plan regulatory strategies...

  • Regulatory Affairs Project Manager

    4 weeks ago

    Santa Clara, United States Tek Support Full time

    We are seeking a Regulatory Affairs Project Manager to oversee and coordinate regulatory activities for our medical devices. The role involves planning, preparation, and submission of regulatory strategies and submissions to the FDA and international agencies, ensuring compliance and supporting market entry of instrument hardware and software.Key...

  • Regulatory Affairs Project Leader

    2 weeks ago

    Santa Clara, California, United States Collabera Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Project Leader to join our team at Collabera. The successful candidate will be responsible for leading regulatory projects and ensuring compliance with US and international regulations.Key Responsibilities:Develop and implement regulatory strategies and priorities in conjunction with management...

  • Regulatory Affairs Project Leader

    4 weeks ago

    Santa Clara, United States Collabera Full time

    Job DescriptionJob Description·         Education: Bachelor's degree required, Master’s degree preferredHave you got the right qualifications and skills for this job Find out below, and hit apply to be considered.·         Experience: Minimum of 3 years of Regulatory Affairs experience·         Skills: Knowledge of US and/or...

  • Regulatory Affairs Project Leader

    4 weeks ago

    Santa Clara, United States Collabera Full time

    Job DescriptionJob Description·         Education: Bachelor's degree required, Master’s degree preferred·         Experience: Minimum of 3 years of Regulatory Affairs experience·         Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or...

  • Medical Device Regulatory Affairs Project Manager

    4 weeks ago

    Santa Clara, United States The Fountain Group Full time

    Details:Pay for this position is 46.00 to 50.00 hourly depending on experience.This position is a one year contract with the possibility of extension or conversion to permanent. Location: Santa Clara, CA – 100% onsite. Education and Experience Required:Bachelor’s Degree in life sciences or engineering, or other technical disciplineTechnical or Medical...

  • Medical Device Regulatory Affairs Project Manager

    4 weeks ago

    Santa Clara, United States The Fountain Group Full time

    Details:Pay for this position is 46.00 to 50.00 hourly depending on experience.This position is a one year contract with the possibility of extension or conversion to permanent. Location: Santa Clara, CA – 100% onsite. Education and Experience Required:Bachelor’s Degree in life sciences or engineering, or other technical disciplineTechnical or Medical...

  • Regulatory Affairs Specialist

    4 weeks ago

    Santa Clara, California, United States Intellectt Inc Full time

    Regulatory Affairs SpecialistJoin Intellectt Inc as a Regulatory Affairs Specialist and play a critical role in ensuring the compliance of our medical devices with regulatory agency specifications. As a key member of our team, you will be responsible for performing specialized level work assignments and analyses, preparation, and submission of documentation...

  • Regulatory Affairs Specialist

    4 days ago

    Santa Clara, California, United States Shockwave Medical Full time

    Job SummaryThe Principal Regulatory Affairs Specialist at Shockwave Medical is a key member of our team, responsible for ensuring that our medical devices meet regulatory requirements. This role requires a strong understanding of scientific, regulatory, and business issues, as well as excellent communication and project management skills.Key...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Santa Clara, California, United States Shockwave Medical Full time

    Job Title: Senior Regulatory Affairs SpecialistShockwave Medical is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and...

  • CMC Regulatory Affairs Director

    2 months ago

    Santa Clara, California, United States Bayside Solutions Full time

    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...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Santa Clara, California, United States Shockwave Medical Full time

    Job Title: Senior Regulatory Affairs SpecialistShockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Santa Clara, California, United States Shockwave Medical Full time

    Job Title: Senior Regulatory Affairs SpecialistShockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated...

  • Regulatory Affairs Specialist

    4 weeks ago

    Santa Clara, California, United States Collabera Full time

    Job DescriptionCollabera is seeking a highly skilled 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 Responsibilities:Support the regulatory department in ensuring compliance with regulatory requirementsAssist...

Regulatory Affairs Project Manager

5 months ago

Santa Clara, United States GForce Life Sciences Full time

Responsibilities:

  • Assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system.
  • Develop an understanding of Clip products and manufacturing processes to review and assess proposed product changes within the change management system.
  • Provide regulatory support for manufacturing-related submissions and international submissions and renewals.
  • Support change management activities, including RA impact assessments in Change Requests, Submissions, and approval of change orders.
  • Review and approve product release process and addendum labeling.
  • Act as an RA project team member for new quality system process changes and updates.


Requirements:

  • Education: Bachelor's degree required, Masters degree preferred.
  • Experience: Minimum of 3 years of experience in regulatory affairs.
  • Industry: Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry preferred.
  • Skills: Knowledge of US and/or Canadian regulations relating to product and/or device clearance (FDA). Effective verbal and written communication skills, negotiation skills, and conflict management skills. Ability to work constructively with internal customers to solve problems and communicate regulatory needs. Ability to manage and track broad and strategic projects. Demonstrated ability to work effectively in a team environment.