Katalyst CRO
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Regulatory Affairs Specialist II
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Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Specialist II
role at
Katalyst CRO This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail. Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation. Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications. Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc. Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications (U.S.) for changes that do not require a 510(k) submission. Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.). Submit notifications to the EU Notified Body for significant changes to CE marked products. Maintain Regulatory documentation. Support special projects, as needed.
Job Description
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail. Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation. Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications. Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc. Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications (U.S.) for changes that do not require a 510(k) submission. Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.). Submit notifications to the EU Notified Body for significant changes to CE marked products. Maintain Regulatory documentation. Support special projects, as needed.
Requirements
B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry. 2-5 years Medical Device experience. Working knowledge of industry consensus standards and FDA guidance is required. At least 2 years Regulatory Affairs experience in Medical Device regulations. Demonstrated success in taking products through FDA and EU Notified Bodies. Working knowledge of 510(k), MDD 93/42/EEC. Regulatory Affairs Certified RAC (RAPS). Proficient in using Microsoft Office. Strong communication and project management skills. Must be able to handle multiple tasks. Attention to detail. 510(k), MDR. 21 CFR 820 - Quality System Regulation, ISO 13485. Medical device standards and FDA guidance relevant to medical devices. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Legal Industries
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Regulatory Affairs Specialist II
role at
Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Specialist II
role at
Katalyst CRO This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail. Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation. Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications. Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc. Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications (U.S.) for changes that do not require a 510(k) submission. Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.). Submit notifications to the EU Notified Body for significant changes to CE marked products. Maintain Regulatory documentation. Support special projects, as needed.
Job Description
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail. Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation. Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications. Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc. Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications (U.S.) for changes that do not require a 510(k) submission. Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.). Submit notifications to the EU Notified Body for significant changes to CE marked products. Maintain Regulatory documentation. Support special projects, as needed.
Requirements
B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry. 2-5 years Medical Device experience. Working knowledge of industry consensus standards and FDA guidance is required. At least 2 years Regulatory Affairs experience in Medical Device regulations. Demonstrated success in taking products through FDA and EU Notified Bodies. Working knowledge of 510(k), MDD 93/42/EEC. Regulatory Affairs Certified RAC (RAPS). Proficient in using Microsoft Office. Strong communication and project management skills. Must be able to handle multiple tasks. Attention to detail. 510(k), MDR. 21 CFR 820 - Quality System Regulation, ISO 13485. Medical device standards and FDA guidance relevant to medical devices. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Legal Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Specialist jobs in
Secaucus, NJ . Regulatory Affairs Specialist - Quality/Regulatory
Totowa, NJ $60,000.00-$65,000.00 1 month ago New York, NY $90,000.00-$137,000.00 2 days ago Bronx, NY $150,000.00-$170,000.00 1 day ago Quality Assurance Compliance Specialist - Cosmetics & Skincare
Totowa, NJ $65,000.00-$75,000.00 2 days ago New York, NY $75,000.00-$95,000.00 2 days ago Clerical Associate - Administrative Law & Regulatory Litigation
Regulatory Affairs & Safety Associate, HH
Parsippany, NJ $86,000.00-$128,000.00 3 days ago Morristown, NJ $77,000.00-$87,000.00 2 weeks ago New York, NY $127,000.00-$150,000.00 1 week ago Regulatory Affairs Supervisor - Cosmetics & Skincare
Totowa, NJ $67,000.00-$72,000.00 2 weeks ago Madison, NJ $115,000.00-$140,000.00 4 days ago Regulatory Review and Compliance Inspector
Regulatory Affairs Specialist - Nutritional Products
VP, Regulatory Affairs Specialist (Regulatory Exams)
New York, NY $140,000.00-$170,000.00 2 weeks ago AVP, Regulatory Affairs Specialist (Branch Inspection)
New York, NY $130,000.00-$145,000.00 2 weeks ago New York City Metropolitan Area $120,000.00-$175,000.00 2 days ago Regulatory Affairs Manager New York City
New York, NY $140,000.00-$150,000.00 2 weeks ago Scientific & Regulatory Affairs- Sr. Specialist
Newark, NJ $107,071.00-$147,223.00 2 weeks ago Medical Devices, Regulatory Affairs Lead
New York, NY $143,000.00-$200,000.00 1 day ago Elmwood Park, NJ $160,000.00-$185,000.00 1 week ago Associate Director, Global Regulatory Affairs
New York City Metropolitan Area $77,000.00-$102,000.00 1 day ago New York, NY $225,000.00-$225,000.00 3 months ago Franklin Lakes, NJ $130,400.00-$215,200.00 1 month ago Legal and Compliance Department - Consumer and Regulatory Compliance Team Intern
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr