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Principal Biologist/Regulatory Specialist, Power and Renewables (Principal Level)
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a. Principal Biologist/Regulatory Specialist,. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
Principal Regulatory Affairs Specialist
The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed. Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance ...
Power Resources Specialist I/II (Regulatory Compliance & Policy) - Energy Department
The department is seeking to fill one (1) full-time Power Resources Specialist I/II position to support the Regulatory Compliance and Policy Division. Under general direction of the Deputy Director, this position will be responsible for supporting the division’s engagement in state regulatory affair...
Sr. Regulatory Affairs Specialist / Manager -510K Focus
Regulatory Affairs Specialist/Manager will oversee medical device development and market introduction, ensuring compliance with regulatory standards for Class I, II, and III devices. Regulatory Affairs Specialist / Manager. Prepare and review regulatory submissions to the US FDA, including 510(k) an...
Regulatory Affairs Specialist
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:. ...
Sr. Regulatory Affairs Specialist / Manager
Regulatory Affairs Specialist/Manager will oversee medical device development and market introduction, ensuring compliance with regulatory standards for Class I, II, and III devices. Regulatory Affairs Specialist / Manager. Prepare and review regulatory submissions to the US FDA, including 510(k) an...
Senior Regulatory Specialist - Environmental
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...
Senior Regulatory Affairs Specialist (Hybrid/Milpitas, CA)
Represents RA in new product development team(s) by providing regulatory guidance, such as anticipating regulatory obstacles and emerging issues, and identifying solutions, through the product development cycle and coordinating cross functional team inputs. Responsible for assessing and documenting ...
Senior Specialist, Regulatory Affairs, Critical Care
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...
Senior Regulatory Specialist - Environmental
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...
Regulatory Affairs Specialist
Education:Minimum or higher in Engineering [Regulatory Engineer] or in a Science field (preferable) [Regulatory Specialist]. Experience:Minimum 3 years relevant experience working in a medical device company (can be in combination with a regulatory degree; , Masters in Regulatory Science) and/or ap...
Global Regulatory Affairs Senior Specialist
Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. Regulatory Affairs Senior Specialist, Global Market Protection. The Regulatory Affairs Senior Special...
Senior Staff Regulatory Affairs Specialist (Hybrid)
Senior Staff Regulatory Affairs Specialist. Senior Staff Regulatory Affairs Specialist. Open Field Visualization premarket regulatory team, specifically supporting business development activities, actively participating in the integration of Regulatory roles and responsibilities for newly acquired t...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist (Multiple Positions), Becton Dickinson and Company, Milpitas, CA. Apply deep understanding of global regulatory landscape to analyze and compile country-specific regulatory requirements. Participating in setting regulatory operation process, including the regulat...
Senior Regulatory Affairs specialist
Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics...
Regulatory Affairs Specialist 3
The specialist works across the organization in supporting design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts on a wide range of products. Develop regulatory pathway for US FDA and Canada new product registration, support p...
Principal Biologist/Regulatory Specialist (Principal Level)
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a . Principal Biologist/Regulatory Specialist. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
Associate Regulatory Labeling Specialist
As part of the team that ensures our labels meet the user's needs, the Associate Regulatory Labeling Specialist will work closely with other departments across the organization, making this an entry-level position that offers a unique breadth of exposure to different medtech compliance and design fu...
Regulatory Affairs Specialist 3
The specialist works across the organization in supporting design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts on a wide range of products. Develop regulatory pathway for US FDA and Canada new product registration, support p...
REGULATORY AFFAIRS SPECIALIST 3.
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...
Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)
Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. Acts as a regu...
Regulatory Affairs Specialist
Engineering [Regulatory Engineer] or in a Science field (preferable) [Regulatory Specialist]. Provide regulatory insight to development, new product introduction, and manufacturing teams for assessing the impact of design inputs and outputs on regulatory filings and compliance. Additional responsibi...
Senior Regulatory Affairs Specialist
Regulatory Affairs Specialist Locations: Sunnyvale, CA Job Type: On-site, FTE Salary Range: 80K-140K Responsi...
Regulatory Affairs Specialist - Contractor
In this role, you will… Perform regulatory assessments for product changes including regulatory reportability decisions Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions Support regulatory...
Senior Regulatory Affairs Specialist
With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs. Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files. Candidate expertise includes det...