Regulatory Affairs Manager
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Tarsus is seeking a Manager I, Regulatory Affairs Operations in Irvine, CA. You will manage electronic submission tools (Veeva Vault RIM) and drive the dossier lifecycle while aligning with FDA/EMA guidelines. The role emphasizes planning, archiving, and coordinating cross‑functional teams to meet tight deadlines. You will lead content planning, support submissions, and help evolve regulatory operations processes. #J-18808-Ljbffr
- Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product... ...AI-powered features) and product lifecycle management Lead preparation and submission of...SuggestedWork at office
- ...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
- ...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
$180k - $200k
...regulations, and partners with executive leadership to mitigate regulatory risk while enabling efficient global commerce. The Director... ...Importer Self‑Assessment (ISA), Duty Drawback, and Reconciliation. Manage exposure to trade remedies and regulations, including IEEPA,...Suggested$120k - $168k
About the RoleThe Manager II, Compliance will partner with the Compliance Department in developing, implementing, and maintaining an... ...of ethics and compliance, and (2) meets or exceeds applicable regulatory standards for effective compliance programs, including the Office...SuggestedWork at officeLocal area$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...Full timeWork at officeLocal area$226.5k - $317.1k
About the RoleThe Senior Director Regulatory Affairs Strategy will play a key role in guiding assigned projects throughout development and lifecycle management by providing regulatory thought leadership and leveraging their extensive development experience. The individual...Work at officeLocal areaRemote work- ...you ready to join us?This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance... ...standards of quality as we help people see brilliantly. The Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting...Hourly payFull timeTemporary workLocal areaRelocation packageFlexible hours
- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases... ..., regulatory compliance, and commercial impact. Hiring Manager Title SVP, Chief Regulatory Officer Functions...
- ...We leave no client behind. General Description: MFG is seeking a detail‑oriented Compliance Manager to join our firm. In this position, you will perform a variety of regulatory compliance and risk management duties. Additional responsibilities may include credit monitoring...Local area
- ...Diality Inc. is seeking a Regulatory Affairs Director to lead regulatory policies and oversee product clearances. You will develop regulatory strategies for the Moda-flx Hemodialysis System and manage submissions with the FDA and other regulatory bodies. The ideal candidate...Remote work
- ...Facebook, Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy... ...global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST...Work at officeWorldwide
- ...Facebook, Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy... ...global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST...Work at officeWorldwide
$174k - $246k
...the needs and interests of the patients we serve. The Director, Regulatory Counsel reports to the Vice President, Regulatory Counsel and... ...Counsel will closely partner with Marketing, Clinical Affairs, Regulatory Affairs, Compliance and other functional groups within...Full time- ...Alcon is seeking a Manager I in Regulatory Affairs Strategy to coordinate compliance activities and lead projects in Lake Forest, California. This role involves collaboration with various stakeholders to secure product approvals and drive regulatory strategies. The ideal...
- ...A global pharmaceutical company is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies for product... ...at least 7 years of regulatory experience, strong project management skills, and the ability to interface with major regulatory agencies...
$173k - $245k
...Edwards' global compliance policies and programs; proactively manage and evolve the global policy ecosystem; provide strategic direction... ...efforts that strengthen operational excellence and regulatory adherence. Oversight and management of government inquiries related...Full timeWork experience placementLocal area$175k - $230k
...Director, Public Sector Consulting - Regulatory Compliance & GrantsLocations: Chicago, IL... ...focus on regulatory compliance, grants management, and operational advisory services. This... ...Public Administration, Public Policy, Public Affairs, Accounting or related field; Master’s...Full timeLocal areaRemote workFlexible hours- ...Sr. Manager / Director, Regulatory Affairs Relocation Required to Southern CA Role Overview We are seeking an experienced regulatory affairs leader to drive strategy, oversee submissions, and guide interactions with global health authorities. This individual will play...Relocation
- ...meet the needs of any professional dialysis care setting. The Regulatory Affairs Director is responsible for overseeing, developing, and... ...This position is also responsible for supporting the Quality Management System and will serve as the Regulatory Affairs lead on product...Work at officeLocal areaRemote work
$85k - $130k
Job SummarySr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory... ...& ResponsibilitiesOwnership of regulatory objectives in the management of international and domestic registrations of a product and...Work experience placementLocal areaWorldwideFlexible hours- ...Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance... ...technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/...
$86k - $114k
...States and its allies. Operating in a fast-growing, high-impact environment, we take creative ownership of complex regulatory matters to build and manage efficient, top-tier compliance processes. We are deeply passionate about the law and policy of defense technology and...Full timeFor contractorsWork experience placementImmediate start$114.91k - $141.95k
...Consultant - Contract to HireLocation:CA - IrvineWhat you'll do:As a Compliance Assistant Manager you'll be a subject matter expert and provide advice, oversight and guidance related to regulatory compliance risks, control effectiveness, root cause analysis, and issue review...Full timeContract work- ...technology or similar. 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the IVD industry. Knowledge of FDA,... ...skills. Thorough knowledge of policies, practices and procedures related to Regulatory Affairs....
- ...position is responsible for the preparation of regulatory submissions required to market medical... ...registrations and related regulatory affairs activities, including execution of... ...Office Strong communication and project management skills Must be able to handle multiple tasks...Work at office
$92k - $148.35k
...dignity of our employees and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category:... ...required, EU MDR experience preferred.Ability to effectively manage multiple projects and priorities.Strong communication and regulatory...Full timeContract workTemporary workLocal areaImmediate startFlexible hours3 days per week$99.7k - $152.08k
...licensing, classifications, technical data reviews, audits, and restricted-party screening.Familiarity with engineering, document management, ERP, or compliance systems.Experience supporting information security and controlled technical data requirements.Work...Permanent employmentFull timeFor contractorsCasual workWork at office- ...support in the maintenance of an effective consumer lending compliance audit program. QualificationsMandatory Skills• Compliance Management• Compliance audit• Statutory CompliancesOther technical skills:• Thales Chorus compliance auditing, scoring, management compliance...
- Regulatory Affairs Specialist II (hybrid) The Regulatory Affairs Specialist III, will provide administrative and technical support to regulatory... ...provides direct Worldwide Regulatory support to lifecycle management and new product development/new product introduction...Full timeWork at officeWorldwideDay shift
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