Regulatory Affairs Manager
Katalyst HealthCares & Life Sciences
Job-ID
Reference
Responsibilities:
- In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more
- You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions
- Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management
- Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies
- Oversee and coach a team of regulatory professionals to support both strategic and operational objectives
- Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.)
- Define and execute submission strategies to meet timelines and business goals
- Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review
- Monitor changes in international regulatory environments and communicate impacts to internal teams
- Represent the company in industry groups or regulatory associations, where appropriate
- Support training and knowledge-sharing on country-specific regulatory requirements within the organization
Requirements:
- BS/MS degree or equivalent experience required
- Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR
- Superior presentation skills when communicating with all levels of the organization, business partners, and external sources
- Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment
- Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Manager in Irvine, CA vacancy
- ...Director in developing and executing regional regulatory strategies for QOL initiatives within... ...and Associate Director. Contribute to managing regulatory risks and opportunities... ...preferred. 5+ years of experience in regulatory affairs within the pharmaceutical or biotech...Suggested
$125k - $145k
...difference. About the Role MicroPort Scientific America is seeking a highly experienced and credentialed Project Manager, Vertical Marketing and Regulatory Affairs, to lead and execute regulatory and go-to-market strategy on high profile projects across our medical device...SuggestedFull timeWork at officeLocal areaMicroPort
Irvine, CA1 day ago- We are searching for a Director of Regulatory Affairs with deep expertise in invasive electromechanical medical devices and extensive experience... .... Provides regulatory guidance on design controls, risk management, biocompatibility, sterilization validation, and usability...Suggested
$131k - $195k
We saved the Compliance Manager spot at MedTech Solutions for someone who treats Contract Negotiation like a question worth asking again... ...than the title suggests. Key Responsibilities Carry the Regulatory Compliance thread across three time zones and two tools Pressure...SuggestedContract workFreelanceFlexible hoursDay shift- ...Head of Global Regulatory Strategy About the Company Global biopharmaceutical company... ...approvals, label expansions, and lifecycle management, while leading interactions with U.S.... ...should bring at least 15 years of regulatory affairs experience and 10 years supporting...Suggested
- ...Head of Global Regulatory Strategy About the Company Global biopharmaceutical company... ...with a strong background in regulatory affairs, particularly within the biotechnology,... ...regulatory strategy, as well as experience in managing large global teams in a matrixed...
- ...Facebook, Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy,... .... Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post...Worldwide
- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead to develop and implement global strategies to secure and maintain market... .... You will lead the Global Regulatory Product Team and manage regulatory life cycle strategies across development and post-...Worldwide
$80k - $100k
...Regulatory Affairs SpecialistAre you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology... ...will have the opportunity to:Support the regulatory team managing international and domestic filings/registrations, including...Work experience placementWorldwideDanaher Corporation
Irvine, CA2 days ago- Latham & Watkins is seeking an OGC Supervisor - Conflicts to oversee the conflicts team and daily operations across US offices. The role combines supervision, process improvement, and staff development in a hybrid work setting. Responsibilities include leading complex conflicts...
- ...Senior Manager Regulatory Affairs role responsible for developing and implementing US and Canada regulatory strategy for assigned pharmaceutical products, managing FDA interactions, and ensuring compliance with regulatory requirements throughout the product lifecycle....
AbbVie
Irvine, CA24 days ago - ...Job Summary:The Assurance Manager is responsible for supervising, directing, and reviewing the results through the delegation of tasks... ...will include advising the client on various economic and regulatory risks within their industry, resolving complex accounting issues...Work at office
BDO International
Costa Mesa, CA1 day ago - ...We are seeking an experienced Principal Consultant / Product Management Advisor with a strong background in Product Management, Portfolio Strategy, Product Roadmap Development, and PLM Product Platform Management. The ideal candidate will help establish and drive a product...Contract work
Neshent Technologies
Irvine, CA24 days ago - ...preferred) and a minimum of 10 years of fundraising and/or operations experience, with a proven track record in leading diverse staff and managing various fundraising programs. Excellent interpersonal, communication, and leadership skills are essential, as is the ability to...
- ...include the ability to attract, develop, and retain a high-caliber team, as well as strong analytical, organizational, and project management skills. Experience in a complex hospital system, academic medical center, or children's hospital setting is preferred, and the...
$33 - $36 per hour
...adherence to prevailing wage laws, certified payroll requirements, and regulatory reporting. This individual will partner closely with internal... ...and compliance reviews of contractor and subcontractor records Manage and track documentation within compliance systems (e.g.,...Full timeFor contractorsFor subcontractorWork at officeLocal area$89.2k
...are looking to hire an enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid work mode) supporting our rapidly... ...control and quality system regulations Ability to simultaneously manage several projects Proficiency with Microsoft Office...Hourly payWork at officeLocal areaRelocationShift work3 days per week- Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions... ...relationships within the Regulatory Affairs functional areas and the Operations and Research...
- Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning... ...documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/...
- ...Strong written and verbal communication skills, accuracy, confidentiality, professional judgment, organization, follow‑through, time management, and ability to manage multiple deadlines while following Team Lead direction and department process. Ability to prepare clear...For contractorsApprenticeshipFor subcontractorWork at officeLocal areaRemote work
- Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables. Prepare Quality Assurance/Regulatory reports and present status in review meetings...Immediate start
- ...policies and provide such information to project teams and management. Develop and implement regulatory strategies and processes to ensure timely global... ...required. A minimum of 4 years of experience in Regulatory Affairs or other related discipline in the medical device...Local areaWorldwide
- ...program. You will be responsible for monitoring and analyzing regulatory requirements, internal policies, and industry standards to ensure... ...preparation and submission of compliance reports to senior management and regulatory authorities. Maintain comprehensive and accurate...Work at office
- The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge provided... ...focused on U.S. FDA Class III submissions and lifecycle management. Proven experience drafting and leading FDA IDEs, 510(k)s,...Full timeContract workRemote work3 days per week
$125k - $130k
...hesitate, come and join us! About This Opportunity - Senior Regulatory Affairs Specialist On this role, the Senior Regulatory Affairs Specialist... ...) applications. Demonstrate practical knowledge of project management, in addition to writing, coordination, and execution of...Work at office- ...needs of any professional dialysis care setting. The Principal Regulatory Affairs Specialist will serve as a key contributor responsible for... ...work products, and drives activities to completion while managing multiple priorities and timelines. Responsibilities Lead the...Work at office
$40 - $46 per hour
...Administration, Information Systems or related discipline or equivalent combination of education and experience. 1-3 years of Database Management experience. Experience in Trade Compliance and Import/Export operations. Working knowledge of CBP import regulations and the...Hourly pay- ...Departments (AHJs) in a timely manner. The Compliance Coordinator works closely with field technicians, Coordinators, and the Portfolio Manager to move inspections through the full cycle from inspection to repair to retest while maintaining high standards of accuracy,...Hourly payWeekend work
$23 - $25 per hour
...Specialist) will be responsible for assisting the Compliance Team Manager with all tasks associated with tracking the communities the... ...needs to be done to come into compliance. Stay Abreast of Regulatory Changes Civil Code and laws are added, removed and changed constantly...Full timePart timeWork at officeLocal areaMonday to FridayFlexible hoursWeekend workAfternoon shift- ...Related Field. Proficiency In Microsoft Office Applications. Knowledge Of Applicable Laws And Regulations. Risk Assessment And Management Experience. Ability To Interpret And Apply Regulations. Bachelor's Degree In Law. Business. Finance Technical Skills:...Work at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Manager. Be the first to apply!
Related searches
- head compliance Irvine, CA
- regulatory & compliance manager Irvine, CA
- regulatory affairs manager pharmaceutical Irvine, CA
- regulatory affairs director Irvine, CA
- regulatory affairs manager medical devices Irvine, CA
- manager regulatory affairs Irvine, CA
- senior regulatory manager Irvine, CA
- compliance director Irvine, CA
- compliance manager Irvine, CA
- sr. manager regulatory compliance Irvine, CA