Regulatory Affairs Specialist II
Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Regulatory Affairs Specialist II
Title:Regulatory Affairs Specialist II
The DAVIS Companies has partnered with a global leader in the medical device industry by securing a Regulatory Affairs Specialist II to join their team.
Responsibilities of Regulatory Affairs Specialist II:
- Prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objective set by divisional and corporate staff.
- Inform project teams of new and changing regulatory requirements.
- Update RA procedures as needed to ensure the company is in compliance with new and changing regulatory requirements.
- Keep abreast of new and changing regulatory requirements.
- Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.
- Review and approve technical literature (labeling, IFU’s, manuals, patient guides, etc.), sales and marketing literature, and reimbursement literature related to company products.
- Review and approve ECO's for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance to existing regulatory submissions.
- Regulatory representative on new product development teams.
- Prepare Annual PMA Report and associated PMA Supplements as required.
- Create and maintain Essential Requirements Checklists, CE Technical Files and Declarations of Conformity for all products bearing the CE Marking.
- Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions as directed.
- Ensure regulatory compliance to FDA and international regulations.
Technical Skills for Regulatory Affairs Specialist II:
- Knowledge and ability to review and approve ECO's and corporate SOP's.
- Sound knowledge and understanding of how IDE regulated clinical studies are performed.
- Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but not limited to FDA, PMAA, IDE, 510(k) Notifications, Medical Device Directive, and European Standards.
- Bachelor's degree in Science or Engineering (or related field) from an accredited college or university. A minimum of Five to Seven years direct experience in quality/regulatory affairs (preferably in the medical device/drug or biomedical
- Proven effective leadership skills to guide, mentor, and develop staff members to perform under stress to meet or exceed project schedules and corporate filing deadlines.
- Effective facilitation skills to motivate engineers, marketing personnel and/or clinical staff to deliver information related to submission preparation and/or direct product literature review, both technical and sales marketing pieces.
- Knowledge and ability to develop, review and approve technical literature as it relates to product specifications and that is consistent with domestic and international regulations.
- Sound knowledge and understanding of company products as they relate to medical device law and international medical devise requirements
- Equipment Operator 2nd Shift in Flowery Branch GA
- Electrician - Control Panel Builder in Brooklyn Park MN
- Assembly Mechanic - Mechanical Assembly in Santa Fe Springs CA
- Warehouse Supervisor in Olive Branch MS
- 2nd Shift Manufacturing Supervisor in Newton MA
- Machine Operator - 2nd shift in South Grafton MA
- Technician in Concord MA
- Inside Sales Rep in Golden CO
- Electrical Manufacturing Technician - Control Panel Builder in Oakdale MN
- Quality Assurance in Mansfield MA
- Public Relations Manager in Lowell MA
- Jr. Buyer in Hudson NH
- Manufacturing Associate in Hudson MA
- Final Assembly in Norcross GA
- Machine Operator in Duluth GA
- Application Engineer in Lawrenceville GA
- Buyer - Planner in Peabody MA
- Administrative Assistant in Duluth GA
- Mechanical Engineer in Norcross GA
- Press Brake Machine Operator in Peabody MA
- Electro Mechanical Assembler in Lowell MA
- Chemistry Technician I in Golden CO
- Controls Engineer in Mt. Washington KY
- Electronic Assembly Technician in Plymouth MN
- Estimator in Pendergrass GA
- Assembly-Production Tech in Golden CO
- Assembler, CT in Buford GA
- Material Handler, Kitting 1st Shift in Buford GA
- Quality Engineer in Maple Grove MN
- Quality Inspector II - PCBA in Westborough MA
- Shipping & Recieving in Alpharetta GA
- Estimation Technician in Memphis TN
- CAD Modeler in Carrolton GA
- Associate Videographer in Milford MA
- Senior Software Test Engineer in Milford MA
- Inventory Clerk in Rochester NH
- Computer - Production Technician in Rochester NH
- Operations Manager in Memphis TN
- Material Handler III in Milford MA
- Accounts Receivable Coordinator in Billerica MA
- Collections Specialist in Norwell MA
- Machine Operator III in Bridgeport NJ
- Machine Operator I in Bridgeport NJ
- Payroll-HR Clerk in Millville NJ
- Credit Specialist in Memphis TN
- Material Handler in Holliston MA
- EM Assembler in Holliston MA
- Warehouse - General Labor in Oxford MA
- Electronic Technician in Memphis TN
- Accounts Payable Specialist in Milford MA
- Test Operator in Nashua NH
- EM Assembler in Leominster MA
- Order Picker in Wilsonville OR
- Associate CMM Layout Engineer in Milford NH
- Maintenance Technician 2nd Shift in Flowery Branch GA
- Entry Level Staff Accountant in Golden CO
- Maintenance Mechanic in Maple Grove MN
- Senior Manufacturing Engineer in Milford MA
- Document Control Specialist in North Billerica MA
- CNC Turning Machinist in Milford MA
- Wire Harness Assembler in Brooklyn Park MN
- Maintenance Mechanics - 2nd and 3rd shifts in Lincoln RI
- Assembler-Kitter in Norwood MA
- Electrical Design Engineer in Fairburn GA
- Manufacturing Engineer in Portsmouth NH
- Shipping and Receiving Supervisor in Westborough MA
- Custodian in Westborough MA
- Production Supervisor in Conyers GA
- Candidate Experience Coordinator in Manhattan NY
- Diesel Technician in Lilburn GA
- Shipping Clerk in Brooklyn Park MN
- Controls Technician in Portland ME
- Engineer, Navigation Systems 18-0054 in Alhambra CA
- Sr Electrical Designer in Minneapolis MN
- IT Technician in Norcross GA
- Quality Engineer in Dover NH
- Packaging technician in Sutton MA
- Advanced Panel Builder in Brooklyn Park MN
- 2nd Shift Production Supervisor in Brooklyn Park MN
- Endoscope Technician in Memphis TN
- Field Service Technician in Franklin MA
- Industrial Engineer II in Maple Grove MN
- Executive Assistant in Newton MA
- Logistics Clerk in Franklin MA
- Machine shop Lead - Supervisor - Operations Support in Central Manchester CT
- Preventative Maintenance Tech - NJ in Vineland NJ
- Optical Technician in Franklin MA
- Mechanical - Incoming Inspector in Hudson NH
- 1st Shift Machine Operator in Sutton MA
- EHS Technician - Environmental Health & Safety Tech in Maple Grove MN
- Material Handler in Duluth GA
- Software Engineer in Hollis NH
- MOCVD Section Manager- 18-0011 in Alhambra CA
- Product Engineer in Milford NH
- Maintenance Mechanic in Shrewsbury MA
- Electronics Technician in Framingham MA
- Logistics Coordinator in Bartlett TN
- Test Tech - 2nd shift in Westborough MA
- Test Operator 2nd shift in Westboro MA
- Solder Assembler II-III 2nd shift in Westboro