Regulatory Affairs Specialist - Medical Devices (FDA/EU)
Adagio Medical Inc.
Adagio Medical Inc. in Laguna Hills is seeking a Regulatory Affairs Specialist responsible for regulatory submissions and ensuring compliance with industry standards. This role involves supporting documentation for FDA and EU registrations, interacting with various departments, and ensuring that products meet regulatory requirements. Ideal candidates will have over three years’ experience in the medical device sector and must possess a relevant Bachelor's degree. Strong analytical and communication skills are essential for this position. The company fosters an inclusive workplace where all backgrounds are valued. #J-18808-Ljbffr Adagio Medical Inc.
$90k - $100k
...Job Title: Regulatory Affairs Specialist Pay: $90,000 - $100,000 Reports to: Chief... ...submissions and registrations (FDA and EU regulatory entities). IDE,... ...Technical Files, Device Master Records, Essential... ...Regulatory Specialist within the medical device industry. Bachelor'...Medical deviceWork at officeWorldwide$170k - $200k
...and institutions to develop elegant medical devices. Our products are being used by physicians... ...this opportunity - Senior Principal Regulatory Affairs Specialist Description The Sr.... ...experience in preparation of US and EU submissions # Experience interfacing...Medical device- ...Job Summary The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn’s pharmacy, manufacturing, and healthcare operations meet all applicable... ...and state regulations related to pharmaceuticals, medical devices, and controlled substances. Key Responsibilities...Medical device
- ...Job Title: Senior Regulatory Affairs Specialist Supervisor/Manager Title: Senior Manager... ...for investigational device applications, commercial registrations... ...changes for impact on US, EU, and international... ...to 8 years of experience in medical device regulatory affairs....Medical device
$120k - $155k
...Lead regulatory strategy and submission activities for Qnovia's drug-device combination products across FDA, MHRA, and other global regulatory bodies... ...Kingdom. As a Regulatory Affairs Specialist, you will develop and... ...the pharmaceutical or medical device industry Direct...Medical deviceLocal areaFlexible hours- ...Regulatory Affairs Specialist Responsibilities: Represent Regulatory Affairs on cross-functional... ...and regulatory requirements for non-medical devices, and medical devices. Assess the... ...years working in a regulated industry (FDA and Software as a Medical Device...Medical device
- ...Principle Regulatory Affairs Strategy Associate The Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of... ...compliance to drive competitive advantage. Support products in the medical device and/or pharmaceutical families, ensuring adherence to all...Medical deviceLocal area
- ## Senior Regulatory Affairs AssociateApplyremote type: Not applicablelocations: Lake Forest, Californiatime type: Full timeposted on: Posted... ...compliance to drive competitive advantage* Support medical device and/or pharmaceutical products, ensuring adherence to relevant...Medical deviceHourly payTemporary workLocal areaRelocation packageFlexible hours
- Principal Regulatory Affairs Strategy Associate Exciting development Principal Regulatory Affairs... ...helping people see brilliantly. The largest device company in the world - with... ...Contract (Potential Extension) Benefits: Medical, Dental, Holiday, PTO 401K matching The...Medical deviceContract work
- ...Description: JOB PURPOSE: · Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. · Serve... ...biomarkers. · Ensure alignment with FDA expectations for Breakthrough Device Designation...Medical device
- ## Senior Regulatory Affairs AssociateApplyremote type: Not applicablelocations: Lake Forest, Californiatime type: Full timeposted on: Posted... ...compliance to drive competitive advantage* Support medical device and/or pharmaceutical products, ensuring adherence to relevant...Medical deviceHourly payTemporary workLocal areaRelocation packageFlexible hours
- ...overseeing quality engineering activities within an IVD medical device manufacturing environment, ensuring compliance with FDA and ISO standards. The ideal candidate will... ...in quality operations with a focus on regulatory requirements. The role includes responsibilities...Medical device
- ...Applied Medical in Rancho Santa Margarita is seeking an Associate Labeling Specialist to support regulatory labeling strategy and compliance. This position involves managing labeling projects, ensuring alignment with global regulations, and collaborating with cross-functional...Medical device
- ...functional teams. The ideal candidate will have a Bachelor's degree and over 2 years of experience in the medical device industry, focusing on quality assurance and regulatory compliance. Strong communication and problem-solving skills are essential, along with knowledge of...Medical device
- ...and traceability Ensure compliance with GxP requirements (FDA, EU, ISO) through validated, auditready solutions Lead testing... ...~ Experience within regulated environments (Life Sciences, Medical Devices, or Pharmaceuticals) ~ Deep knowledge of SAP supply chain modules...Medical device
- A medical device company is seeking an experienced engineer to support the design and manufacture of medical devices. This role involves creating... ...skills. Additional qualifications include familiarity with FDA regulations and advanced design techniques for injection...Medical device
$110k - $145k
...management systems, ensuring compliance with FDA 21 CFR 820 and ISO 13485 regulations.... ...pivotal in advancing products through regulatory approval to commercial production. Responsibilities... ...of quality assurance experience in medical device manufacturing. The position offers a...Medical device$71k - $80k
A leading medical device company in California seeks a Process Engineer committed to enhancing manufacturing systems through process improvements, compliance validations, and effective documentation. The role requires a Bachelor’s in engineering and over a year of industry...Medical device$40 - $46 per hour
...Sr. Technical Recruiter | Talent Acquisition | Medical Device, Biotech, Life Sciences, Engineering, Regulated, IT Industries This is an... ...join a Global, industry leading company as a Trade Compliance Specialist. Responsibilities Generate SAP reports to present KPIs in Tier...Medical deviceHourly pay- ...in Lake Forest. This role requires over a decade of hands-on experience in embedded software development, particularly in the medical device sector. The ideal candidate will be proficient in C++ and C, with a strong understanding of object-oriented design patterns. You...Medical device
$200k - $240k
...regulated product software, Software as a Medical Device (SaMD) and software supporting STAAr’s... ...closely with Quality Assurance, Regulatory Affairs, Research and Development, Manufacturing... ...audits by regulatory agencies (ex. US FDA, EU Notified Bodies, etc.), supplier audits...Medical device- A leading medical device company in Rancho Santa Margarita is seeking an Associate Specialist in Premarket Regulatory Affairs to support product development and regulatory compliance. You will engage with cross-functional teams and contribute to maintaining high-quality...Medical device
$71k - $80k
Applied Medical is a new generation medical device company with a proven business model and commitment to... ...Description The Associate Labeling Specialist supports regulatory labeling strategy and quality... ...within the Regulatory Affairs Labeling team at Applied Medical...Medical deviceLocal area$70k - $80k
Overview Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by... ...Description Join Applied Medical as an Associate Specialist in Premarket Regulatory Affairs and help shape the future of medical...Medical deviceLocal area$111.15k - $138.94k
...substances in order to investigate their applications to the medical device industry. Large complexity and sized project involvement is the... ...preferred. Pharmaceutical industry experience a plus. Key Specialist in specific areas of discipline (Advanced Career Level). Desired...Medical deviceWork at office- ...is an ophthalmic medical technology corporation... ...Surveillance Specialist supports regulatory compliance,... ...support the Clinical Affairs and Product Surveillance... ...with applicable FDA and international... ...for the medical device industry.... ...regulation for US, EU, Canada, and other...Medical deviceWork at officeLocal area
$24 per hour
...General Information Name Medical Device Assembler Employment Type Temporary Position level Full-time Virtual/Remote? No Labor Category Electronic Assembly Date 25-Jun-...Medical deviceFull timeTemporary workLocal areaImmediate startRemote workWorldwideDay shift$19 per hour
...duties associated with electro-mechanical and clean room device assembly and packaging. The role requires manual hand... ..., procedures, Good Manufacturing Practices, and FDA regulations including compliance with Medical Device Quality Standards. Comply with company Standard...Medical deviceContract workTemporary workImmediate startMonday to ThursdayDay shift- ...A renowned medical device company in California is seeking a Quality Inspector to ensure product integrity and compliance. The ideal candidate will inspect and test materials during manufacturing, collaborate with cross-functional teams, and maintain detailed documentation...Medical device
$55k - $75k
...to support the assembly and testing of ultrasonic nebulization devices. The role involves hands-on assembly, maintaining process control... ...ensuring product quality. Candidates should have experience in medical device manufacturing, familiarity with cleanroom protocols, and...Medical deviceFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist - Medical Devices (FDA/EU). Be the first to apply!
- regulatory Laguna Woods, CA
- regulatory affairs Laguna Woods, CA
- compliance lead Laguna Woods, CA
- regulatory compliance Laguna Woods, CA
- regulatory affairs assistant Laguna Woods, CA
- compliance team leader Laguna Woods, CA
- compliance technician Laguna Woods, CA
- customs compliance Laguna Woods, CA
- regional compliance officer
- accounting compliance officer


