Global Medical Device Regulatory Affairs Specialist
Implant Direct
Implant Direct in Thousand Oaks, CA is seeking a Regulatory Affairs Specialist to manage global regulatory submissions for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role represents Regulatory Affairs on cross-functional teams, provides regulatory strategy, assesses impact of design changes, and ensures ongoing compliance across markets while supporting audits and regulatory developments. #J-18808-Ljbffr Implant Direct
- Implant Direct, part of Envista Holdings, seeks a Regulatory Affairs Specialist to manage global regulatory submissions for medical devices from Thousand Oaks, CA. You will coordinate 510(k) filings, CE documentation, and international dossiers, working with cross-functional...Medical device
- ...Description Job Description Sr. Regulatory Affairs Specialist 100% ONSITE in Westlake... ...for this role Caldera Medical’s Mission - To Improve the... ...and implement medical device regulatory strategies to... ...accurately prepared and comply with global regulations. The position...Medical deviceWork at officeLocal areaWorldwide
$85.8k - $104.8k
## Implant Direct Regulatory Affairs Specialist (Thousand Oaks, CA)Applylocations: United States of America, California... ..., preparing, coordinating, and managing global regulatory submissions and registrations for medical devices, including US 510(k), EU technical documentation...Medical deviceWorldwide- ...DBA-Verwaltungs-Gmbh is seeking a Global Trade Specialist to lead compliance in the import and export of medical devices across the United States. The role involves managing customs processes, trade risk mitigation, and collaboration across various functions. The ideal...Medical device
- ...Medical Device Assembler We are looking for a precise, quality-driven medical device assembler to join our 2nd shift production team.... ...where following exact specifications, maintaining a high level of dexterity, and adhering to strict regulatory standards. RandstadMedical deviceAfternoon shift
- ...Regulatory Operations Specialist **on site in Westlake Village, CA - no remote option** Caldera Medical’s Mission - To Improve the Quality of Life for... ...solutions. Our Regulatory Affairs team keeps that mission... ...quality, or a related medical device function — or a strong...Medical deviceFor contractorsLocal areaRemote workWorldwide
- ...submissions. ~ Experience working with Notified Bodies and global regulatory agencies for product approvals and compliance matters Our... ...Compensation, Comprehensive Benefits, and more! ~ Medical and Dental Benefits ~ Vision Coverage ~401(k) with 4% matching...Full timeLocal areaWorldwide
- Envista Holdings Corporation seeks a Product Development Engineer to drive New Product Development for surgical implants, prosthetics, and instruments. You will contribute to concept development, design, verification, validation, and transfer to production, collaborating...Medical device
$98.7k - $120.7k
...EngineeringMinimum 2 years’ experience in product development; medical device or another highly regulated industry is highly... ...conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening...Medical deviceFull timeContract work$45 - $51.41 per hour
...Support cross-functional coordination for medical device and combination product development... ...team members across engineering, quality, regulatory, clinical, manufacturing, supply chain,... ...Solutions: US Tech Solutions is a global staff augmentation firm providing a wide...Medical deviceHourly payContract work$79k - $119k
...involves driving execution of molding technologies, improving efficiency, and ensuring compliance with global quality and regulatory standards in the medical device industry. The role will also include collaboration with cross-functional teams, vendors, and management...Medical deviceTemporary workWork experience placementFlexible hoursShift work$20 - $23 per hour
...Description Job Description Assembler Job Summary Assemble medical devices and tools in a clean room environment. Work with small parts,... ...clients each year. Aerotek is an Allegis Group company, the global leader in workforce and business solutions. To learn more,...Medical deviceWeekly payContract workTemporary workWork at office$175k - $195k
...driving force behind everything we do. As a global leader with the most comprehensive... ...performing team of sales representatives and specialists through clear performance expectations,... ...Diagnostics, life sciences, pathology, medical device, or laboratory workflow experience....Medical deviceFull timeContract workRemote workWork from homeFlexible hoursNight shift$145.56k - $196.93k
...marketing experience within pharmaceutical, biotech, healthcare, or medical device industries• Manage, Coach and Develop staff in L&P roles to... ...for multiple priorities• Experience working with sales team, regulatory, legal, compliance, vendor management as client or functional...Medical deviceFull timeRemote workHome officeFlexible hours- ...vaccines. With operations in the U.S. and Europe, they supply global pharmaceutical and biotech companies with critical tools for developing... ..., and production scheduling principles Experience in medical device, biopharmaceutical, life sciences, or other FDA/ISO-regulated...Medical deviceWork at officeRemote work
$211.41k - $286.02k
...while ensuring patient safety, worker safety and regulatory compliance across our global operations.This is a highly visible... ...Process Development, Quality, Manufacturing, Medical Device Engineering, Regulatory Affairs and EHSS.Influence enterprise decisions through...Medical deviceFull timeRemote workFlexible hours$168.39k - $227.83k
...containers, and drug-delivery device combination products, as they... ...(ISO 10993-17) for medical devices.Prepare and/or manage... ...categorize hazards according to the Globally Harmonized Standard (GHS) for... ...Support scientific work including regulatory compliance, trade...Medical deviceFull timeWork at officeRemote workFlexible hours- ...Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas:... ...Lifecycle & Periodic Review Specialist Location: Hybrid Position Summary We... ...and improvement opportunities. Support regulatory inspections, audits, and client...Medical device
$40 - $60 per hour
...experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with... ...delivered thousands of GxP projects globally. As part of the USDM team, you have... ...preferred. Knowledge of quality and regulatory requirements pertinent to pharmaceutical...Medical deviceHourly payFull timeTemporary workPart timeWork experience placementWork at officeRemote workHome office$20 per hour
...Description: We are looking for a precise, quality-driven Medical Device Assembler to join our 2nd Shift production team. In this role... ...maintaining a high level of dexterity, and adhering to strict regulatory standards are paramount. location: Agoura Hills, CA...Medical deviceTemporary workWork experience placementLocal areaAfternoon shift$60 - $69.09 per hour
...connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our... ...needed Drug Safety Pharmacovigilance Medical review/ Safety Review location:... ...Conduct reportability assessment for medical device associated events and /or product complaint...Medical deviceHourly payContract workTemporary workWork experience placementLocal areaRemote workWorldwide- ...Who we are? United Imaging is a leading global medical device developer and supplier with a diversified portfolio of advanced medical products, digital healthcare solutions, and intelligent solutions that cover the entire process of imaging diagnosis and treatment. From...Medical deviceTemporary workFor contractorsFor subcontractorLive inWork at officeLocal areaRemote workWorldwideRelocationOverseas
- ...pricing recommendations, and partner with regional sales to drive execution and launches. Ideal candidates will have 6+ years in medical device sales, proven experience with healthcare systems contracting, and a track record of growing account penetration and revenue #J...Medical device
$83.97k - $113.61k
Career Category Regulatory Job Description Join Amgen’s Mission of Serving Patients... ...Related Conditions Therapeutic Area (TA). Global Regulatory Affairs (GRA) provides global regulatory... ...industry (e.g., biotech/pharma, medical device, clinical research, healthcare) Experience...Medical deviceFlexible hours$148.69k - $177.26k
...will serve as a central point of contact, respond for educating medical professionals and external stakeholders on disease state... ...of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience. Associate degree and 6...Medical devicePrivate practiceLive inWork at officeLocal areaRemote workFlexible hoursNight shift- ...technical architecture into structured validation frameworks Executive presence and cross-functional leadership Experience in medical device, pharmaceutical, cold chain, IoT hardware, or cloud platforms is highly preferred. Why This Role? This is an opportunity to shape...Medical device
- ...Global Program Management RoleJoin a global program management team at a large biotech pharmaceutical leader, supporting medical device and combination product development from early stages through... ...with engineering, quality, regulatory, clinical, manufacturing, supply...Medical deviceRemote work
- Caldera Medical in Westlake Village, CA is seeking a National Sales Director - Surgical to lead the growth and scale of our Surgical field... ...managers and reps. The position requires 8+ years in medical device sales leadership, with proven revenue responsibility of $50M-$2...Medical device
- Caldera Medical, based in Westlake Village, CA, seeks a Sales Recruiter with firsthand sales experience to build our sales organization. You will own full-cycle recruiting for sales roles—from associates to regional leaders—collaborating with sales leadership to hit quota...Medical device
- ...hybrid role requiring 2-3 days onsite. Candidates should have at least 5 years in complaints handling and failure analysis in medical devices. A bachelor's degree in engineering or relevant sciences is preferred. Strong communication and presentation skills are essential...Medical device
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Medical Device Regulatory Affairs Specialist. Be the first to apply!
- medical specialist Thousand Oaks, CA
- health care worker Thousand Oaks, CA
- patient care technician Thousand Oaks, CA
- healthcare support staffing Thousand Oaks, CA
- health care assistant Thousand Oaks, CA
- medical records specialist Thousand Oaks, CA
- patient care technician pct Thousand Oaks, CA
- patient transport technician Thousand Oaks, CA
- medical management specialist Thousand Oaks, CA
- healthcare assistant Thousand Oaks, CA



