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Regulatory Affairs Jobs in San Diego, California

Vp Quality And Regulatory Affairs
By Proven Recruiting At San Diego, CA, United States
Management review of quality and regulatory team.
Manage the preparation and development of regulatory submission packages.
Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
Prior experience authoring and filing of regulatory documents.
Responsible for regulatory submission strategies to support product development and approval of various medical device products.
Interface with regulatory authorities and internal technical teams on regulatory submissions.
Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121 $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Senior Regulatory Affairs Specialist
By NuVasive, Inc. At , San Diego $96,000 - $160,000 a year
Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
Knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.
This position is remote eligible, but we prefer candidates commutable to our San Diego, CA office
Ability to determine, communicate and make recommendations for submission and approval requirements to others
Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs
Understanding of regulatory terminology, pre-market submission types, and requirements
Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121, Ca $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Senior Regulatory Affairs Associate/Specialist
By SciPro At San Diego, CA, United States
Be able to provide support to regulatory management and project teams and implement regulatory strategy while delivering documentation on time.
Maintain and manage databases containing regulatory information, submissions, and correspondence.
BS in life sciences with a minimum of 3 years of experience in Regulatory Affairs
Experience submitting IND filings utilizing eCTD formatted submissions highly desirable.
Independently plan daily work to complete time-sensitive assignments while following general instructions for project completion.
Review documents necessary for the regulatory site documentation related to the shipment of drug products to clinical sites.
Head Of Regulatory Affairs - Igt-D
By Philips At , San Diego, Ca
Extensive experience and knowledge required of global medical device regulations, requirements, and standards;
Leading strategic AOP management to optimize revenue
10 years of people management – with a strong track-record in successfully leading a Regulatory Affairs team
Experienced in strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities);
*Montana employees are currently excluded from this requirement at this time.
In return, we offer you
Vice President, Regulatory Affairs
By Escient Pharmaceuticals, Inc. At , San Diego, 92121, Ca $270,000 - $325,000 a year
In-depth knowledge of global regulatory requirements
Establish and maintain relationships with senior regulatory consultants and advisors; manages regulatory vendors and budget
Ensure compliance with applicable regulatory reporting requirements, laws and regulations
Science degree (PhD, PharmD, MD, MSc) with extensive experience in regulatory leadership
Minimum of 10 years of experience in Regulatory Affairs in the biopharmaceutical industry
Prior experience in dermatology or immunology and inflammation preferred
Regulatory Affairs Specialist(100% Remote) $95K
By CyberCoders At Carlsbad, CA, United States
3-5+ years of professional OUS EUMDR Regulatory Affairs experience
Experience with Medical Device Reg Affairs for implantable
Working knowledge of 21 CFR 820, ISO 13485, MDD, EU MDR, and MDSAP
Full Benefits: Medical, Dental, Vision for employee and all dependents!
Bleeding Edge Technology = smart device to control pain relief!
Maintain licenses/registrations in existing territories
Executive Director, Regulatory Affairs Strategy
By Neurocrine Biosciences At San Diego, CA, United States
Provides strategic guidance on global regulatory requirements to management and project teams
Detailed knowledge of FDA/EMA/ICH regulations and guidance for global drug development, preparation and management of IND/CTA/MAA/BLA/NDA applications
Regulatory experience and detailed knowledge outside the US (Japan and/or EU) is preferred
Manages preparation of all regulatory submissions (IND/CTA/MAA/BLA/NDA)
Master's degree preferred and 15+ years of related experience, OR
PhD and 12+ years of related experience OR
Regulatory Affairs Specialist 1 Jobs
By Hologic At , San Diego, Ca $65,000 - $89,600 a year
Understanding of product life cycle process, design control and/or risk management.
Participate on product development core teams as regulatory representative and provide guidance on global regulatory requirements for new/existing products.
Interpret and clearly explain regulatory requirements and standards for IVDs and medical device products to cross-functional stakeholders.
Prepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned).
Bachelors with 1 years of experience or Masters with 0 year of industry experience or equivalent
Technical knowledge including (but not limited to) Biomedical/Life Sciences/Engineering/Clinical.
Global Regulatory Affairs Coordinator
By CooperVision At , San Ramon, Ca $62,285 - $83,046 a year
Interfaces with management and department.
Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
Conducts self in a professional manner with colleagues, management, customers, and others. Models the corporate values.
Maintains contracts and invoice coordination with respect to Regulatory requirements.
No significant travel. Occasional requirements to attend offsite meetings.
Have attention to detail with organizational skills
Staff Software Regulatory Affairs Analyst (Remote)
By BD At , San Diego, 92130, Ca
Direct experience with Medical Device Software regulations IEC 62304 / 82304, IEC 60601.
5+ year's validated experience with regulated medical device development.
Validated understanding of QMS, demonstrating experience in supporting QMS process implementation using methodologies that promote compliant and agile software development practices.
Minimum of 5 years’ validated experience working with US 510(k)/PMA and CE Tech Files including software-driven medical devices and related products.
Knowledge of hardware-based device development, compliance testing, and documentation (i.e., traceability, integration, verification) a plus.
Certifications (RAC, CQA, CQM, etc.) preferred.
California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Regulatory Affairs Program Manager, Us
By ZEISS Group At Dublin, CA, United States

The Regulatory Affairs Program Manager US is responsible for developing and monitoring regulatory submission timelines for a variety of US medical device submissions (such as 510(k)s, IDEs and/or ...

Regulatory Affairs Analyst Jobs
By San Jose Water At San Jose, CA, United States
Required Knowledge Skills & Abilities
· Working knowledge of statistics, investments, budgeting, project management and computerized applications.
· The Regulatory Affairs Analyst requires substantial technical skill in finance, economics, and statistics.
· Utility rate-making methodologies and legal requirements.
· Excellent written and oral communication skills.
· A bachelor's degree or equivalent in finance, economics, accounting, engineering or a closely related field.
Senior Manager Regulatory Affairs
By Jasper Therapeutics At Redwood City, CA, United States
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
Must be able to effectively identify data needs, and successfully present to management.
Manage/track regulatory submission documents and timelines, collaborating with Clinical Operations and CROs to ensure timely submissions of all deliverables.
Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
Maintain up-to-date knowledge of current regulations for applicable territories. •
Other tasks and responsibilities as directed by the Regulatory Affairs leadership team.
Regulatory Affairs Consultants Jobs
By Pharmatech Associates, a USP company At San Francisco, CA, United States
Develop, lead, and drive the execution of the regulatory strategy from pre-IND to launch, commercialization and product lifecycle management
Responsible for communicating business-related issues or opportunities to next management level
Plan and oversee activities in support of all regulatory submissions
Provide regulatory guidance to the Client across all areas of regulatory affairs throughout all stages from product development
Participate as part of internal regulatory team to define and execute the regulatory strategy
Support the preparation of briefing packages, and regulatory submission documents as needed , providing insight and expertise
Regulatory Affairs Manager Jobs
By Ardelyx, Inc. At Fremont, CA, United States
Develop and maintain knowledge of regulatory requirements and industry trends independently and with line manager.
Ability to interpret and understand regulatory and cGXP requirements and apply to regulatory submissions and job duties.
Experience in FDA CMC submissions utilizing eCTD format and electronic submissions.
Proficient in Microsoft Suite products, experience with VEEVA RIM preferred.
Ability to independently manage timelines in a project team environment.
Maintain awareness of and expertise in FDA and ICH guidelines related to regulatory topics.
Head Of Regulatory Affairs
By Life Science People At Torrance, CA, United States
Proven people management experience, with a track record of building and leading high-performing teams
Participate in the development and implementation of regulatory strategies to support product approvals, license maintenance, and lifecycle management
Collaborate with cross-functional teams to ensure that regulatory requirements are integrated into product development plans and timelines
Strong knowledge of FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs
Excellent writing, communication, and interpersonal skills
Prepare and maintain CMC documentation for various applications, including NDAs, DMFs, CEPs, INDs, etc.
Director Of Regulatory Affairs (Cell Therapy)
By GQR Global Markets At San Francisco Bay Area, United States
Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.
Depth Knowledge of GLP and GCP regulatory requirements in domestic and globally.
Manage all aspects of nonclinical and clinical regulatory strategy development for products (early- to late-stage/registration/post-market).
Prior experience with cell or gene therapies (preferred)
Prior experience in oncology drug development
10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.