Current jobs related to Director, Regulatory Affairs - Redwood City - Pulmonx
-
Regulatory Affairs Director
3 days ago
Redwood City, California, United States MFS Talent Full timeMFS Talent is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for providing strategic and operational regulatory input and support to collaboration with other project team members. Your expertise will contribute to the development of regulatory plans and strategies,...
-
Regulatory Affairs Director
2 days ago
Redwood City, California, United States HealthCare Recruiters International Full timeDirector of Regulatory AffairsHealthCare Recruiters International is seeking a seasoned Director of Regulatory Affairs to lead the regulatory function for a global leader in robotic systems for surgical interventions.Regulatory Leadership: Provide overall leadership of the regulatory function, interfacing with Clinical, Quality Assurance, and CMC...
-
Regulatory Affairs Director
2 weeks ago
Redwood City, California, United States Pulmonx Corporation Full timeJob SummaryWe are seeking a highly experienced Regulatory Affairs Director to join our team at Pulmonx Corporation. As a key member of our leadership team, you will be responsible for implementing regulatory strategies worldwide to ensure compliance with regulatory requirements and obtain regulatory approval for our products.Key ResponsibilitiesRegulatory...
-
Regulatory Affairs Director
5 days ago
Redwood City, California, United States Work In Biotech Full timeTransformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...
-
Regulatory Affairs Director
2 weeks ago
Redwood City, California, United States HealthCare Recruiters International Full time**About the Role**HealthCare Recruiters International is seeking a highly qualified Director of Regulatory Affairs to join our team. As a key member of our R&D team, you will play a critical role in the development and commercialization of innovative robotic systems for the diagnosis and treatment of patients with advanced surgical interventions.**Key...
-
Regulatory Affairs Director
2 weeks ago
Redwood City, California, United States Adverum Biotechnologies, Inc. Full timeAbout the RoleWe are seeking a highly experienced Regulatory Affairs Director to lead our CMC Regulatory strategy for our gene therapy programs. As a key member of our team, you will be responsible for developing, executing, and advising on global Regulatory CMC strategies across all phases of our development programs.Key ResponsibilitiesRegulatory Strategy...
-
Regulatory Affairs Director
3 weeks ago
Redwood City, California, United States Pulmonx Full timeAbout PulmonxPulmonx is a leading medical device company dedicated to developing innovative solutions for respiratory health. We are seeking an experienced Regulatory Affairs Director to join our dynamic team.Key ResponsibilitiesRegulatory Strategy Development: Develop and implement comprehensive regulatory strategies that align with company goals and ensure...
-
Regulatory Affairs Director
2 days ago
Redwood City, California, United States Work In Biotech Full timeTransformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...
-
Regulatory Affairs Director
2 weeks ago
Redwood City, California, United States Adverum Biotechnologies Full timeAbout the RoleWe are seeking a highly experienced and skilled Regulatory Affairs Director to lead our CMC Regulatory strategy for Adverum's gene therapy program/s. As a key member of our team, you will be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of our development program/s.Key...
-
Director of Regulatory Affairs
2 weeks ago
redwood city, United States HealthCare Recruiters International Full timeOur client is a global leader in the development and commercialization of first-in-class robotic systems for the diagnosis and treatment of patients in need of advanced surgical interventions, including solid tumors. They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small...
-
Director of Regulatory Affairs
2 weeks ago
redwood city, United States HealthCare Recruiters International Full timeOur client is a global leader in the development and commercialization of first-in-class robotic systems for the diagnosis and treatment of patients in need of advanced surgical interventions, including solid tumors. They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small...
-
Director, Regulatory Affairs
3 weeks ago
Redwood City, United States Pulmonx Corporation Full timeThe Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below.Support Product Development & Registration:Provides strategic input and technical guidance on...
-
Director, Regulatory Affairs
6 days ago
Redwood City, United States Work In Biotech Full timeWhy Nuvig Be a part of a potential game-changer for patients with autoimmune disease! Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment...
-
Director of Regulatory Affairs
2 weeks ago
redwood city, United States MFS Talent Full timeShift: Days - 8 hours, Monday-Friday, 40hrs/weekLocation: Onsite, Palo Alto, CACompensation: $180k-$230k annually Duties and ResponsibilitiesResponsible for strategic and operational regulatory input and support for collaboration with other project team members, including regulatory team members. Contributes to the development of regulatory plans and...
-
Director of Regulatory Affairs
2 weeks ago
Redwood City, United States MFS Talent Full timeShift: Days - 8 hours, Monday-Friday, 40hrs/weekLocation: Onsite, Palo Alto, CACompensation: $180k-$230k annually Duties and ResponsibilitiesResponsible for strategic and operational regulatory input and support for collaboration with other project team members, including regulatory team members. Contributes to the development of regulatory plans and...
-
Director of Regulatory Affairs
2 weeks ago
Redwood City, United States MFS Talent Full timeShift: Days - 8 hours, Monday-Friday, 40hrs/weekLocation: Onsite, Palo Alto, CACompensation: $180k-$230k annually Duties and ResponsibilitiesResponsible for strategic and operational regulatory input and support for collaboration with other project team members, including regulatory team members. Contributes to the development of regulatory plans and...
-
Director of Regulatory Affairs
2 days ago
Redwood City, United States Work In Biotech Full timeWhy Nuvig Be a part of a potential game-changer for patients with autoimmune disease! Our client Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases. Nuvig's treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term...
-
Director of Regulatory Affairs
4 days ago
Redwood City, United States Work In Biotech Full timeWhy Nuvig Be a part of a potential game-changer for patients with autoimmune disease! Our client Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases. Nuvig's treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term...
-
Director of Regulatory Affairs
3 days ago
redwood city, United States Work In Biotech Full timeWhy Nuvig Be a part of a potential game-changer for patients with autoimmune disease! Our client Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases. Nuvig's treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term...
-
Redwood City, California, United States Arcellx Full timeAbout the RoleWe are seeking a highly experienced Senior Director, Clinical Regulatory Affairs to lead our clinical regulatory approval strategy and implementation. As a key member of our team, you will be responsible for overseeing post-approval regulatory requirements and cultivating productive relationships with regulatory authorities and cross-functional...
Director, Regulatory Affairs
3 months ago
Responsibilities:
The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below.
Support Product Development & Registration:
- Provides strategic input and technical guidance on global regulatory requirements to product development and clinical teams.
- Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
- Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions.
- Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans.
- Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
- Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships.
- Provides regulatory guidance on strategy for proposed product claims/labeling.
- Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
- Manages electronic and paper registration development.
- Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
- Prepares cross-functional teams for interactions with regulatory authorities including panel meetings/advisory committees.
Support Post approval/Post market Activities:
- Ensures process is in place for review and approval of advertising and promotion to ensure regulatory compliance.
- Develops, implements, and manages systems to track required reports, supplemental submissions, and other post marketing commitments.
- Reviews and approves required reports, supplemental submissions, and other post marketing commitments to maintain product registrations.
- Reviews and approves change controls to determine the level of change and consequent submission requirements.
- Develops, implements, and manages appropriate SOPs and systems to track, manage, report, and communicate product-associated event complaints, recalls, market withdrawals and vigilance reports.
- Adapts post market strategy based on consideration of factors such as HTA, reimbursement, group purchasing pressures, state/provincial/ regional restrictions, and other legislative/regulatory requirements.
Other Responsibilities
- Serves as companys deputy Person Responsible for Regulatory Compliance (PRRC).
- Participates in Corporate initiatives as appropriate.
- Supports Quality Policy and Quality System.
Requirements:
- Bachelors degree and a minimum of 12 years of experience in Regulatory Affairs in the medical device industry.
- Demonstrated strength in regulatory submissions activities. Class III, PMA experience is strongly desired.
- Commercial and post-market experience is required.
- Knowledge of international regulatory requirements, EU MDR.
- Strong project management skills and experience.
- Proficient in timely review of technical data and clinical data.
- Demonstrated success in fast-paced start-up, entrepreneurial work environments.
- Ability to write clear, concise, and well thought out technical documents.
- Strong leadership, organizational, interpersonal skills.
- Excellent presentation skills.
- Computer skills: MS Word, PowerPoint, Excel
- Hybrid role.
- Minimal travel (less than 10%).
