Regulatory Affairs Professional
4 weeks ago
Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches
- Product Registration Experience: Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files
- Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
- Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
- Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1 as evidenced by coursework or submissions that required use of each standard
Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
Regulatory Affairs Professional
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Regulatory Affairs
4 days ago
Palo Alto, United States The Judge Group Full timeOur client is currently seeking a Regulatory Affairs for a 12 month + contract.Hybrid position, 2 days in office (Palo Alto, CA).Position Description: *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements* Identifies, analyzes and implements country specific...
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Regulatory Affairs Specialist
6 days ago
Palo Alto, United States Net2source Inc. Full timeJob Title: Regulatory Affairs Professional 4Duration: 12 months (Possible Extension )Location: Palo Alto CA 94304 (Hybrid)Experience: 5-8 years.Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence....
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Head of Regulatory Affairs, Oncology
1 week ago
Palo Alto, United States Ascendis Pharma Full timeHybridPalo Alto, California, United StatesOncology, Regulatory, OncologyFull time1404 Description We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, and Oncology. Guided by our core values of patients, science, and passion, we use our...
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Regulatory Affairs Specialist
3 weeks ago
Palo Alto, United States Net2source Full timeJob Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hybrid) Experience: 5-8 years. Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence....
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Regulatory Affairs Specialist-4694
1 day ago
Palo Alto, United States Infosoft Full timeOne of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. Here are the job position details for your review: Job Title**:Sr. Regulatory Affairs Specialist** Pay Rate**:$63 to...
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Regulatory Affairs Specialist
3 weeks ago
Palo Alto, United States Net2source Full timeJob Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hybrid) Experience: 5-8 years. Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence....
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Regulatory Affairs Specialist
4 weeks ago
Palo Alto, United States Net2Source Inc. Full timeJob Title: Regulatory Affairs Professional 4Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hybrid)Experience: 5-8 years. Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence....
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Regulatory Affairs Specialist
1 week ago
Palo Alto, United States Net2Source Inc. Full timeJob Title: Regulatory Affairs Professional 4Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hybrid)Experience: 5-8 years. Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence....
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Regulatory Affairs Specialist
4 weeks ago
Palo Alto, United States Net2Source Inc. Full timeJob Title: Regulatory Affairs Professional 4Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hybrid)Experience: 5-8 years. Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence....
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Regulatory Affairs Specialist
1 week ago
Palo Alto, United States Net2Source Inc. Full timeJob Title: Regulatory Affairs Professional 4Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hybrid)Experience: 5-8 years. Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence....
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Manager, Regulatory Affairs
3 weeks ago
Palo Alto, United States Ascendis Pharma Full timeJob DescriptionJob DescriptionHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We are...
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Manager, Regulatory Affairs
2 weeks ago
Palo Alto, United States Ascendis Pharma Full timeJob DescriptionJob DescriptionHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We are...
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Manager, Regulatory Affairs
3 days ago
Palo Alto, United States Ascendis Pharma Full timeHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We are applying our TransCon technology to...
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Manager, Regulatory Affairs
1 week ago
Palo Alto, United States Ascendis Pharma Full timeJob DescriptionJob DescriptionHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We are...
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Regulatory Affairs Specialist(W2 Only)
1 day ago
Palo Alto, United States Infosoft Teksolutions Full timeHere are the job position details for your review: Job Title**:Regulatory Affairs Specialist (W2 Only)** Pay Rate**:$63 to $68.89/HR** Duration**:12 months** Location**:Palo Alto, CA (Hybrid - 2 days/week onsite)** **Must have skills on the Resume**: - **Product Registration Experience**: We are looking for a **Regulatory Affairs Specialist.** - Perform...
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Senior Regulatory Affairs Specialist
3 weeks ago
Palo Alto, United States Cynet Systems Full timeJob Description: Pay Range $63.89hr - $68.89hr Responsibilities: s a Senior Professional, a candidate will leverage candidate extensive expertise, integrating analysis, development, testing, and implementation within the candidate area of competence. Candidates will interpret and functionally influence policy and guidelines, developing processes and systems...
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Sr. Regulatory Affairs Specialist
4 weeks ago
Palo Alto, United States APN Software Services, Inc Full timePlease contact Abdul on "" OR email me at ""*Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements* Identifies, analyzes and implements country specific requirements necessary for product related submissions.*Recommend strategies for earliest possible approvals...
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Senior Regulatory Affairs Specialist
4 weeks ago
Palo Alto, United States Cynet Systems Full timeJob Description: Pay Range $63.89hr - $68.89hr Responsibilities: As a Senior Professional, a candidate will leverage candidate extensive expertise, integrating analysis, development, testing, and implementation within the candidate area of competence. Candidates will interpret and functionally influence policy and guidelines, developing...
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Regulatory Affairs Professional 4
3 weeks ago
Palo Alto, United States JobRialto Full timeDescription: Position Description: Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements Identifies, analyzes and implements country specific requirements necessary for product related submissions. Recommend strategies for earliest possible approvals for...
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Director, Regulatory Affairs, Oncology
2 weeks ago
Palo Alto, United States Ascendis Pharma Full timeJob DescriptionJob DescriptionThe Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and...