Current jobs related to Senior Regulatory Affairs Specialist, IVD Product Lifecycle - San Diego CA United States - Hologic
-
Senior Regulatory Affairs Specialist
2 months ago
San Diego, United States BioTalent Full timeWe are hiring a Senior Regulatory Specialist for an established in-vitro diagnostics company in San Diego, CA. This is hybrid on-site role 3 days per week and requires at least 5-7+ years of hands-on Regulatory experience including 510(k) authorship. ResponsibilitiesCoordinates submission and review of documents for Design History files.Drafts, edits and...
-
Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistAt ACON Laboratories, we are committed to developing innovative medical devices that enhance human life. We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.The ideal candidate will have a strong background in medical devices regulations and terminologies, with a minimum of 6-7 years of...
-
Senior Regulatory Affairs Specialist
1 month ago
San Diego, California, United States BioTalent Full timeSenior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at BioTalent. This is a hybrid on-site role that requires at least 5-7+ years of hands-on Regulatory experience, including 510(k) authorship.Key Responsibilities:Document Coordination: Coordinate submission and review of documents for...
-
Senior Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States BioTalent Full timeBioTalent is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in San Diego, CA. This is a hybrid on-site role requiring at least 5-7+ years of hands-on Regulatory experience including 510(k) authorship. Responsibilities: * Coordinates submission and review of documents for Design History files. * Drafts, edits, and compiles...
-
Regulatory Affairs Specialist
1 week ago
San Diego, California, United States CorDx Full timeAt CorDx, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for assisting in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.The ideal candidate will have a strong understanding of regulatory...
-
Regulatory Affairs Specialist
1 month ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Coordinate the preparation and...
-
Regulatory Affairs Specialist
1 week ago
San Diego, California, United States CorDx Full timeAt CorDx, we are seeking a highly skilled Regulatory Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Assist in the preparation, compilation, and submission of regulatory filings and...
-
Regulatory Affairs Specialist II
1 week ago
San Diego, California, United States Abbott Laboratories Full timeAt Abbott Laboratories, we're seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our Regulatory Affairs department, you'll play a critical role in ensuring compliance with US, EU, and international regulations and standards for our diagnostic products.Key Responsibilities:Provide regulatory support for diagnostic...
-
Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States Cypress HCM Full timeJob OverviewCypress HCM is seeking a highly skilled Regulatory Affairs Specialist to coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies.Key ResponsibilitiesCoordinate submission and review of documents for inclusion in Design History...
-
Regulatory Affairs Specialist II
1 week ago
San Diego, California, United States Abbott Laboratories company Full timeAt Abbott Laboratories company, we are seeking a highly skilled Regulatory Affairs Specialist II to join our team. This role will be responsible for providing regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards.Key Responsibilities:Reviews and approves...
-
Senior Manager Regulatory Affairs Specialist
1 month ago
San Diego, California, United States Sekisui Diagnostics, LLC Full timeAbout You:You are a seasoned professional in the Regulatory Affairs space with specific experience in IVD and POC products. You have a proven track record of success in US regulatory affairs submissions, including 510(k) and/or PMA. With at least 10+ years of experience in this field, you have developed a deep understanding of regulatory requirements and can...
-
Senior Manager Regulatory Affairs Specialist
1 month ago
San Diego, California, United States Sekisui Diagnostics, LLC Full timeAbout the RoleWe are seeking a seasoned professional to join our team as a Senior Manager Regulatory Affairs. This is an exciting opportunity to leverage your expertise in regulatory affairs to drive business growth and success.Key ResponsibilitiesLead the development and implementation of regulatory strategies to ensure compliance with relevant laws and...
-
Senior Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States BD (Becton, Dickinson and Company) Full timeJob Description SummaryAs a Senior Specialist in Regulatory Affairs, you will play a critical role in supporting the development, sustainment, and end-of-life activities of Medical Devices and Non-Medical Devices, as well as associated Software and Accessories, on a global basis from a Regulatory Affairs standpoint.About the RoleThis fully remote position...
-
Regulatory Affairs Expert
1 week ago
San Diego, California, United States Sekisui Diagnostics, LLC Full timeAbout the Role:You will be a seasoned professional in the Regulatory Affairs space with specific experience in IVD and POC products. Your experience in US regulatory affairs submissions, such as 510(k) and/or PMA, will be valuable in this role. With at least 10+ years of experience in this field, you will be able to take the lead with submissions and prepare...
-
Sr. Regulatory Affairs Specialist
2 weeks ago
san diego, United States ACON Laboratories Full timeSenior Regulatory Affairs Specialist (Locals Only with experience composing submissions)At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest...
-
Sr. Regulatory Affairs Specialist
1 month ago
San Diego, United States ACON Laboratories Full timeSenior Regulatory Affairs Specialist (Locals Only with experience composing submissions)At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest...
-
Sr. Regulatory Affairs Specialist
1 month ago
san diego, United States ACON Laboratories Full timeSenior Regulatory Affairs Specialist (Locals Only with experience composing submissions)At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest...
-
Senior Regulatory Affairs Specialist
1 day ago
San Diego, California, United States Neurocrine Biosciences Full timeAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to lead our advertising and promotion regulatory efforts. As a key member of our team, you will be responsible for ensuring compliance with FDA regulations and guidelines for commercial materials.Key Responsibilities:Lead cross-functional collaboration to ensure timely reviews...
-
Regulatory Affairs Specialist
3 weeks ago
San Diego, California, United States Tandem Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Prepare and maintain domestic and international regulatory...
-
Senior Regulatory Affairs Specialist
4 weeks ago
, GA, United States Abbott Full timeAbout AbbottAbbott 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...
Senior Regulatory Affairs Specialist, IVD Product Lifecycle
4 months ago
We are hiring in our Diagnostics Regulatory Affairs team here in San Diego, and are looking for a Senior Regulatory Affairs Specialist, IVD Product Lifecycle responsible for new product development, on-market, and international regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies.
This position is focused on in vitro diagnostic systems including assay, software and hardware. The position requires a person with commitment to excellence, and the ability to work in a fast-paced, technically skilled, team setting.
Essential Duties and Responsibilities
Independently support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core team’s approved scope of regulatory activities, with focus on instrumentation and software/hardware, and experience in assay development. Demonstrated ability to interface with subject matter experts (SME) and regulatory agencies. Demonstrated ability to articulate regulatory risks, potential regulatory challenges, and optimal regulatory strategies. Prepare, compile and publish electronic pre-market and post-market regulatory submissions in approved geographical scope. Compile IVDR compliant Technical Documentation for IVD medical devices to support EU CE-Mark Interact with business partners to support ROW submissions for IVD medical devices (Asia PAC, EMEA, LATAM, Canada etc.).Prepare and maintain international submission dossiers. Develop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on regular basis. Review of product labeling, materials for publication, literature and Web site for accuracy, consistency and regulatory compliance Develop and/or revise regulatory procedures Provide regulatory support to existing and new cross-functional product core teams Review new product design protocols related to verification and validation, risk assessment, etc. Mentor and instruct junior staff members on how to complete key regulatory activities such as submissions. Supervise and take responsibility for the quality of work completed by junior staff on shared projects. Support on-market regulatory activities as assigned by management. Assess and communicate new and/or updated regulations to technical functions within the company.Required Qualifications and Experience
Bachelor's Degree required in the life sciences or biomedical engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within the IVD or medical device industries OR Master’s Degree in biomedical engineering and/or RAC preferred with a minimum of 3-5 years direct experience in Regulatory Affairs within the IVD or medical device industries. Software/instrumentation experience strongly preferred. Point of care molecular IVD test system experience preferred, with knowledge of instrumentation and assaysOther Related Skills:
Demonstrated ability to coordinate complex projects. Strong oral and written communication and presentation skills with ability to participate in complex discussions Solid working knowledge of the US Regulations and European IVD and medical device regulations and directives Good analytical and problem solving skills. Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, with particular focus on laboratory automation and software/hardware components of IVD medical devices. Experience with point-of-care molecular IVDs highly desirable. Experience with International submissions and IVDs highly desirable. Experience working on developing syndromic multiplexed test panels highly desirable Capacity to communicate regulations to technical functions within the company Ability to manage relationships international customers (e.g., regulatory agencies, distributors, etc.) Solid computer skills in Microsoft OfficeWhy join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
From a benefits perspective, you will have a access to benefits such as medical and dental insurance, ESPP, 401(k) plan, vacation, sick leave and holidays, parental leave, wellness program and many more
The annualized base salary range for this role is $111,200 to $173,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
#LI-RF1 #mid-level
