Regulatory Specialist: Average Salary in Carlsbad, CA in 2024

A leading provider in the health care and digital health space is seeking a Senior Regulatory Affairs Specialist to join their regulatory team. As a key player in regulatory oversight, you will help ensure product compliance with global regulatory standards, including ISO 13485 and FDA regulations. ...

Senior Regulatory Affairs Specialist. Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings. Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions. Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK ...

The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...

Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Regulatory Affairs Specialist II:. ...

Program and Regulatory Specialist. The Energy Commission seeks a Program and Regulatory Specialist to fill one position in the Special Projects Unit within the Fuels and Transportation Division. Under general direction of a Program and Project Supervisor, the Program and Regulatory Specialist will s...

The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. Regulatory Compliance - knowledge of federal and municipal regulatio...

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...

The Regulatory Specialist is a part of Research and Development, this team is responsible for assessing ingredient safety and regulatory compliance, coordinating safety, micro, stability, compatibility and claims testing, ensuring product compliance with international cosmetic regulations, and advis...

The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. DUTIES AND RESPONSIBILITIES Regulatory Compliance - knowledge of fed...

Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Review reports of customer complaints and assess them for regulatory reporting. ...

Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...

Job Description: Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA. Provide consultation and advice to regulatory specialists regarding change control and product development. Experience with Japanese and Chinese regulatory submissions. Ability to interpret and apply regulatory requir...

Regulatory Affairs Specialist III – Global Submissions. As a Regulatory Affairs Specialist III at Thermo Fisher Scientific Inc. This is a world-class position where you will collaborate with Regulatory Project Leads to prepare flawless regulatory submissions and ensure their timely delivery to globa...

The program manager will work directly with Product Line Management, Engineering, Services and Manufacturing to understand internal and external customer requirements, develop program plans and drive the program on schedule and budget. The Engineering Program Manager is the key point of contact for ...

The Manager, Regulatory Affairs, is responsible for leading Carlsmed’s regulatory submissions and successfully interacting with regulatory agencies. Lead the Regulatory Affairs function, including creation and/or oversight of US and International regulatory submissions. Represent Regulatory Af...

A growing medical device company based in North San Diego county is hiring a Regulatory Affairs Manager for their QA/RA department. The RA Manager will be responsible for leading the regulatory strategy and managing submissions for new product launches. Prepare, review, and submit regulatory documen...

As a member of PointClickCare’s Legal and Compliance team, In the role of Compliance Analyst, you will be instrumental in driving key initiatives and projects that have a substantial impact on PointClickCare, its customers, and other stakeholders. Assist in the development of, and ongoing updates to...

Reporting to the Senior Director of Regulatory Affairs, the Manager/Senior Manager, Regulatory Affairs will be responsible for strategic and administrative aspects of regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of highest quality, and ...

Ensure product and quality specifications are met at both Processing and Huller Plants. Help achieve and exceed food safety and quality standards per BRC Certification and regulatory requirements (FDA/USDA). ...

Senior Quality Assurance Specialist – Southern California, $90K-$100K. I’m currently partnered with an innovator in connectivity solutions, who are looking for a Senior Quality Assurance Specialist. In this role, you'll play a key part in ensuring compliance with ISO 9001 standards, collaborating ac...

Our client is seeking a highly organized Program Manager with experience in Managed Care and experience managing Information Technology programs and projects. Address program issues by identifying and selecting a course of action by considering the program constraints and objectives to enable contin...

This is a great opportunity for a Project Manager to join Proofpoint and help with our Core Financial initiatives. The Project Manager will have the ability to "think big", be creative and have fun while ensuring change is adopted over the long term. The PM will help to optimize the Core Financial p...

Oversee project activities as assigned by the Project Manager, including planning, coordinating, circumventing/resolving problem areas, ensuring all company/project policies, procedures, and standards are maintained, etc. The Assistant Project Manager is an entry-level project management position an...

Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, CMC Regulatory Affairs, Biologics. ...

The Project Manager will lead cross-functional projects with diverse internal teams to meet business objectives and metrics. The (PM) will provide end to end project management leadership (concept to completion) on the LSG Project Management Team, being fully responsible for the mechanisms which en...