Senior Regulatory Affairs Leader — Med Device, 510(k) Expert
Calyxo, Inc.
Calyxo, Inc. in Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities from concept to commercialization of category-defining medical devices. You will own U.S. and international submissions and partner with R&D, Operations, Quality, Clinical, and Legal to align regulatory strategies with development plans. The ideal candidate has FDA experience, strong technical writing skills, and is able to drive regulatory decisions in a fast-paced environment. #J-18808-Ljbffr Calyxo, Inc.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Leader — Med Device, 510(k) Expert in Pleasanton, CA vacancy
- LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global regulatory strategies for medical devices. The role involves preparing submissions, leading communications... ...affairs, particularly with FDA 510(k) and EU MDR submissions. Strong...Senior
- Calyxo, Inc. in Pleasanton, CA, is seeking an experienced Senior Regulatory Affairs Specialist to support our growing regulatory team. You will... ...You bring solid FDA experience, leading submissions such as 510(k)s and letters to file, with strong cross‑functional communication...Senior
- Abbott in Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to support worldwide submissions and regulatory strategies for medical devices. The role collaborates with product teams and manufacturing to prepare filings and maintain licenses, registrations,...SeniorWorldwide
- NextEra Energy Resources is seeking a Sr PGD Safety Specialist to lead safety programs across the West Wind Hub. You will drive regulatory compliance, conduct field assessments, and guide teams with technical leadership and coaching. The role requires up to 75% travel...Senior
- ...Associate Division Leader (ADL)to supportthe... ...Engineering Division (MED). MED is a... ...as a member MED’s senior leadership team, formulating... ...a subject matter expert and technical contributor... ...Package401(k)Relocation AssistanceEducation... ...of mobile devices in Limited Areas. Depending...SuggestedMinimum wageFull timeTemporary workFor contractorsLocal areaWork from homeRelocationFlexible hours1 day per week
- Jobtailor in Fremont, CA seeks a senior market and product marketing professional to drive... ...strategic launch planning for medical devices. You will lead cross-functional teams to... ...business cases, collaborating with Clinical Affairs and Product Marketing, and forecasting market...Senior
$90k - $180k
...: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted... ...a global healthcare leader that helps people... ...diagnostics, medical devices, nutritionals and... ...The Opportunity This Senior Regulatory Affairs Specialist will work... .... Experience with 510(k) applications, PMA supplements...SeniorFor contractorsWork experience placementWork at office$90k - $180k
...Full timeCategory: Regulatory AffairsIndustry:... ...healthcare leader that helps people... ...diagnostics, medical devices, nutritionals and... ...recruiting for a Senior Regulatory Affairs Specialist to join... ...requirements.Subject Matter Expert (SME) for audits... ...with either 510(k) applications,...SeniorFor contractorsWorldwide- Calyxo, Inc. is looking for a Staff Regulatory Affairs Specialist in Pleasanton, California. This senior role requires 12+ years in regulatory affairs, focusing on leading complex submissions and ensuring regulatory compliance throughout product development. The ideal...Senior
- Senior Regulatory Affairs Specialist - Pleasanton, CA Pleasanton, CA Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA... ...filings (including 510(k)s, letters to file, registrations... ...with experienced, proven leaders and have an opportunity...SeniorWork at officeWorldwideShift work
$130k - $140k
...Engineering or Science, along with 5+ years of experience in medical device development. The role offers a competitive salary between $130,000 - $140,000, stock options, and a comprehensive benefits package including 401(k) and healthcare insurance. #J-18808-Ljbffr CalyxoSenior$182.9k - $274.3k
Workday is seeking a Senior Manager, International Tax to lead critical elements of U.S. international tax compliance and foster collaboration with cross-functional teams. This role emphasizes operational excellence and people leadership, with a focus on improving compliance...SeniorFlexible hours- ...We are partnering with a growing, innovative medical device organization seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy,... ...devices Prepare and manage submissions including FDA 510(k), EU MDR Technical Documentation, CE Mark, and global...SeniorLocal area
- Albertsons Media Collective in Pleasanton, CA, is seeking a motivated professional to join our team. You will help lead initiatives, drive innovation, and contribute to the growth of a company that values outstanding service and lasting customer relationships in a fast-...
- DealHub Ltd. seeks a Salesforce CPQ Subject Matter Expert to own and continuously optimize our CPQ ecosystem and quote-to-cash processes across the organization. You will partner with Sales, Pricing, Finance, Operations, and IT to develop scalable solutions that improve...
- A growing software consultancy in Pleasanton, California is seeking an experienced middleware specialist with at least 7 years of experience in administration and troubleshooting. Candidates should have strong skills in Apache Tomcat, Weblogic, and WebSphere, along with...SeniorFull time
- ...People Business Partner to join our team in Pleasanton, CA. You will drive HR strategy, lead executive coaching, and partner with senior leaders to align workforce plans with business objectives. The role requires 12+ years of HR leadership, exceptional communication,...SeniorRemote workFlexible hours
- ...evaluation and therapy with supervision, program development, and collaboration with teachers, OTs, psychologists, and families in a K-12 setting. Strong leadership, mentorship, and CA SLP licensure are required; relocation and sign-on bonuses are available. #J-18808-...SeniorRelocation package
- Calyxo, Inc. is seeking a Senior Quality Assurance Technician to join our Pleasanton, CA team. You... ...Quality Assurance group to ensure medical devices, assemblies, and components meet engineering requirements and regulatory standards during development. You will perform...Senior
- STN Incorporated is seeking a Senior Accountant to own core general ledger accounting, drive the monthly close, and support financial reporting, audit, and internal control activities. You will prepare journal entries, reconcile balance sheet accounts, and assist with...SeniorFull time
- ...Network is seeking a Project Manager for Walnut Creek / Pleasanton and the broader East Bay. You will lead the delivery of ground-up K-12 school projects, working with owners, architects, consultants and field teams. You will oversee projects from preconstruction through...Senior
- Infini-Tek in Pleasanton, CA seeks a detail-oriented Senior Accountant to ensure the integrity of our financial information. The ideal candidate will manage complex daily accounting tasks, prepare accurate financial statements, lead month-end close processes, and assist...Senior
- Workday is hiring a Senior Accountant in Pleasanton, CA, to join a growing Finance team focused on AI-driven improvements for R2R processes. The ideal candidate thrives in a fast-paced environment and brings strong GAAP knowledge and communication skills. The role involves...SeniorWork at officeRemote workFlexible hours
- The Lawrence Livermore National Laboratory is seeking a Sr. Fire Alarms Electronics Technician to provide technical support for fire alarms and emergency voice alarm systems. This full-time position requires on-site presence at Sites 200 and 300. The successful candidate...SeniorFull time
- ...partnering with Managing Directors and Project Management to win work and protect margin. The ideal candidate operates at a high level, is a STACK expert, and actively uses AI tools to enhance accuracy while understanding limitations. #J-18808-Ljbffr Blueline Associates, Inc.Senior
- Calyxo, Inc. in Pleasanton, CA, seeks a Senior Regulatory Affairs Specialist to independently manage US and international regulatory filings for category-defining medical devices. Join a cross-functional team spanning R&D, Operations, Quality, Clinical, and Legal to ensure...Senior
- Abbott, located in Livermore, CA, seeks a Senior Product Leader to steer a high-performing team focused on innovative healthcare and AI-driven... ..., cross-functional collaboration across AI, clinical, and regulatory groups, and mentoring a team through ideation to launch for...Senior
- ...planning, entitlement, and project delivery while expanding the firm’s NC client base. Working with leadership, marketing, and practice leaders, you will build market strategies, identify opportunities, lead pursuits, and manage relationships #J-18808-Ljbffr DAHLIN...Senior
$263.5k - $310k
...Taiho Pharma Canada, Inc. is seeking a Senior Director for Clinical Pharmacology & Pharmacometrics in Pleasanton, CA. This role is pivotal in overseeing pharmacometric activities and collaborating with various departments to enhance drug development processes for oncology...Senior- Workday, Inc. is seeking a senior leader to guide the Healthcare Value Management team in North America. You will shape value strategies, collaborate with sales and services, and drive outcomes across the full client lifecycle. The role requires building a high-performing...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Leader — Med Device, 510(k) Expert. Be the first to apply!
Related searches
- team lead data science Pleasanton, CA
- team leader mental health Pleasanton, CA
- disability team leader Pleasanton, CA
- quality control team lead Pleasanton, CA
- merchandise team leader Pleasanton, CA
- team leader full time Pleasanton, CA
- quality assurance team leader Pleasanton, CA
- key team leader Pleasanton, CA
- application team lead Pleasanton, CA
- healthcare team leader Pleasanton, CA