Regulatory Affairs Manager
2 months ago
A growing medical device company based in North San Diego county is hiring a Regulatory Affairs Manager for their QA/RA department. The company is developing breakthrough products for the treatment of cardiac arrhythmias and will be commercializing several new products by the end of this year and early next.
The RA Manager will be responsible for leading the regulatory strategy and managing submissions for new product launches. This is a hands-on role that requires a deep understanding of regulatory requirements and processes, particularly in premarket submissions. The ideal candidate will have a blend of hands-on regulatory experience and some management capabilities to guide the team and ensure successful product approvals.
Responsibilities:
• Develop and implement regulatory strategies for new product development and commercialization.
• Prepare, review, and submit regulatory documentation to relevant regulatory bodies (e.g., FDA, EMA) to obtain necessary approvals for new products.
• Ensure compliance with all applicable regulatory requirements and standards throughout the product lifecycle.
• Coordinate and manage regulatory submissions, including premarket notifications (510(k)), premarket approvals (PMA), and CE marking.
• Liaise with regulatory authorities and respond to inquiries to facilitate the approval process.
• Provide regulatory guidance to cross-functional teams, including R&D, Quality, Marketing, and Clinical, to ensure alignment with regulatory requirements.
• Monitor and interpret regulatory requirements and changes, ensuring the company’s products and processes comply with current regulations.
• Develop and maintain regulatory files and documentation, ensuring accuracy and completeness.
• Participate in risk management activities and provide regulatory input for risk assessments.
Qualifications:
• Bachelor’s degree and a minimum of 5 years of regulatory affairs experience in the medical device industry, with a focus on premarket submissions.
• Proven track record of successful regulatory submissions and product approvals.
• Strong knowledge of regulatory requirements and guidelines, including FDA, ISO, and EU MDR.
• Hands-on experience with regulatory submissions, including 510(k), PMA, and CE marking.
• Excellent organizational, communication, and interpersonal skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Experience with electronic submission systems (e.g., eCTD) is preferred.
-
Regulatory Affairs Director
1 month ago
Carlsbad, California, United States Carlsmed Full timeJob Title: Regulatory Affairs DirectorJob Summary:The Regulatory Affairs Director at Carlsmed is responsible for leading the company's regulatory submissions and ensuring successful interactions with regulatory agencies. This role requires a strong understanding of US and international regulatory pathways and the ability to create effective and efficient...
-
Regulatory Affairs Specialist
4 weeks ago
Carlsbad, United States Meet Full timeA leading medical device company is seeking a Regulatory Affairs Specialist to lead the regulatory strategy and manage submissions for new product launches.This is a hands-on role that requires a deep understanding of regulatory requirements and processes, particularly in premarket submissions.The ideal candidate will have a blend of hands-on regulatory...
-
Regulatory
2 months ago
Carlsbad, United States Entegee Full timeJob DescriptionJob DescriptionJob Summary:Manage international regulatory submissions, registrations, and compliance, ensuring timely coordination and project management within the medical device industry.Job Requirements:Minimum 3 years of direct experience in international registration4-5 years as an independent Regulatory Affairs (RA) specialist in...
-
Clinical Affairs Director
1 month ago
Carlsbad, United States Talnt Full timeAbout the RoleWe are seeking a highly experienced Senior Director of Clinical Affairs to lead our clinical collaboration programs, driving forward innovative oncology-focused research. As a key member of our team, you will be responsible for building and managing relationships with academic institutions, research groups, and community practices to execute...
-
Senior Director Of Clinical Affairs
2 months ago
Carlsbad, United States Talnt Full timeAbout the Role As the Senior Director of Clinical Affairs you will spearhead clinical collaboration programs driving forward innovative oncologyfocused research. You will be responsible for building and managing relationships with academic institutions research groups and community practices to execute impactful clinical studies. This role requires a strong...
-
Senior Director Of Clinical Affairs
1 month ago
Carlsbad, United States Talnt Full timeAbout the Role As the Senior Director of Clinical Affairs you will spearhead clinical collaboration programs driving forward innovative oncologyfocused research. You will be responsible for building and managing relationships with academic institutions research groups and community practices to execute impactful clinical studies. This role requires a strong...
-
Senior Director of Clinical Affairs
1 month ago
Carlsbad, United States Talnt Full timeAbout the RoleWe are seeking a highly experienced Senior Director of Clinical Affairs to lead our clinical collaboration programs and drive forward innovative oncology-focused research. As a key member of our team, you will be responsible for building and managing relationships with academic institutions, research groups, and community practices to execute...
-
Global Market Manager
3 days ago
Carlsbad, United States Manpower San Diego Full timeJob Summary: The Global Market Development Manager is responsible for leading the marketing program strategy for hemato-oncology applications in our Clinical Next-Generation Sequencing Division. The successful candidate will be a member of our Global Market Development Team, responsible for setting the strategic direction and tactical implementation of...
-
Clinical Research Associate I
2 days ago
Carlsbad, United States Della Infotech Full timeWork schedule must be flexible based on time zones for project needs. This Remote contract position is part of the Regulatory and Clinical Affairs organization. This position ensures that the internal and external work performed to develop our in vitro diagnostics is in compliance with Good Clinical Practice, applicable regulatory requirements (domestically...
-
Clinical Research Associate I
4 weeks ago
Carlsbad, CA, United States Della Infotech Full timeThis position is part of the Regulatory and Clinical Affairs organization at Della Infotech, ensuring compliance with Good Clinical Practice, applicable regulatory requirements, and FDA submissions for in vitro diagnostics.The primary role of this position is targeted toward clinical studies support and study site management, coordinating and conducting...
-
Senior Quality Assurance Manager
4 weeks ago
Carlsbad, United States Novartis Farmacéutica Full timeJob SummaryThis position is responsible for leading the Quality team to ensure compliant processes, team management, and oversight of the Quality compliance and Quality operations in support of EU, FDA, Clinical Trial, CLIA/CAP, state, and ISO compliance requirements.Key ResponsibilitiesManage personnel and compliance for assay validation, clinical study...
-
Civil Construction Safety Manager
1 month ago
Carlsbad, United States K2 Staffing Full timeJob SummaryK2 Staffing is seeking a highly skilled Civil Construction Safety Manager to join our team. As a key member of our organization, you will play a pivotal role in ensuring the safety of our workforce and compliance with all relevant safety regulations and standards.Key Responsibilities:Develop and Implement Safety Policies and Procedures: Design and...
-
Health and Safety Manager
4 weeks ago
Carlsbad, California, United States Aramark Full timeJob DescriptionWe are seeking a Health and Food Safety Manager to support Aramark food and beverage operations at LEGOLAND California Resort. The successful candidate will coordinate efforts to implement safety and risk control programs, processes, and procedures to protect people, property, environment, and company assets. This role will function as a...
-
Remediation Program Manager
2 weeks ago
Carlsbad, United States ALTAMIRA Full timeRemediation Program ManagerSummaryAs a Remediation Program Manager, you are responsible for overseeing remediation projects, managing staff and subcontractors, engaging stakeholders, and driving financial growth. You will provide technical and regulatory expertise to ensure successful project outcomes and contribute to the company’s financial...
-
Research And Development Manager
1 month ago
Carlsbad, United States Bolt Medical Full timeDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.Responsibilities:Overall: Lead engineering team in support of product development and ensure all work is performed per internal, ISO and regulatory standards. Ensure execution of detailed engineering analyses & documentation to support design...
-
Project Manager II
4 weeks ago
Carlsbad, United States Dennis Group San Diego Full timeJob SummaryDennis Group San Diego is seeking a highly skilled Project Manager II to lead our industrial construction projects from planning to commissioning. As a key member of our team, you will be responsible for ensuring the success of our projects, managing multiple stakeholders, and delivering high-quality results.Key ResponsibilitiesDevelop and...
-
Quality Manager
2 weeks ago
Carlsbad, United States Allen Spolden Full timeJob DescriptionThe Quality Control Manager is responsible for developing and maintaining Quality QC systems for the Analytical department. Achieves organizational objectives through the coordinated achievements of subordinate staff. Establishes departmental goals and objectives and functions with autonomy. Manages the accountability and stewardship of human,...
-
Quality Manager
3 weeks ago
Carlsbad, United States Allen Spolden Full timeJob DescriptionThe Quality Control Manager is responsible for developing and maintaining Quality QC systems for the Analytical department. Achieves organizational objectives through the coordinated achievements of subordinate staff. Establishes departmental goals and objectives and functions with autonomy. Manages the accountability and stewardship of human,...
-
Director of Project Management
1 month ago
Carlsbad, United States Bolt Medical Full timeDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.Responsibilities:Overall: As a Project Management Leader, you lead/manage all cross functional project teams to plan, execute and achieve company objectives from concept through commercial launch.This role puts strong emphasis on agility, strategic...
-
Restaurant Operations Manager
1 month ago
Carlsbad, United States McAlister's - Carlsbad (Pierce Street) Full timeAbout the RoleWe are seeking a highly skilled and experienced General Manager to lead our Carlsbad restaurant team. As a key member of our management team, you will be responsible for overseeing all business operations, ensuring compliance with company safety standards, and driving sales growth.Key ResponsibilitiesManage daily restaurant operations,...