Sr Regulatory Affairs Specialist
2 weeks ago
We are seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing submissions to regulatory bodies.
Key Responsibilities:
- Prepare and submit regulatory documents required for the approval and registration of new and existing products in various markets.
- Stay informed on global regulatory requirements and changes, especially those related to medical devices and surgical sutures, and assess their impact on company products.
- Coordinate with R&D, quality assurance, and other departments to compile necessary documentation for regulatory submissions.
- Advise on regulatory requirements during product development stages.
- Monitor compliance with post-market surveillance and reporting obligations.
- Assist in developing and implementing regulatory strategies to support market entry and expansion.
- Provide regulatory support and guidance to internal teams and external partners.
Qualifications:
- Bachelor’s degree in a related field (e.g., Biology, Chemistry, Medical Engineering).
- Minimum of 3 years’ experience in regulatory affairs within the medical device industry, particularly with contract manufacturing and surgical sutures.
- Familiarity with FDA, EU MDR, and other international regulatory standards and processes.
- Strong organizational skills with the ability to manage multiple projects simultaneously.
- Excellent written and verbal communication skills.
- Proven ability to think analytically and solve problems efficiently.
We offer a competitive salary, comprehensive benefits package, and a collaborative work environment focused on professional growth and development. If you are passionate about contributing to the advancement of medical technologies and meet the above criteria, we would love to hear from you.
Company DescriptionDemeTECH Corporation is a leading manufacturer of medical devices located in Miami Lakes, FL.Company DescriptionDemeTECH Corporation is a leading manufacturer of medical devices located in Miami Lakes, FL.-
Senior Regulatory Affairs Specialist
3 weeks ago
Miami Lakes, United States DemeTech Full timeDemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...
-
Senior Regulatory Affairs Specialist
2 days ago
Miami Lakes, United States DemeTech Full timeDemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...
-
Senior Regulatory Affairs Specialist
1 month ago
Miami Lakes, United States DemeTECH Corporation Full timeDemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...
-
Senior Regulatory Affairs Specialist
1 month ago
Miami Lakes, United States DemeTECH Corporation Full timeDemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...
-
Senior Regulatory Affairs Specialist
1 month ago
Miami Lakes, United States DemeTECH Corporation Full timeDemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Miami, United States DemeTech Full timeDemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...
-
Specialist, Medical Affairs
5 days ago
Franklin Lakes, United States BD Full time**Job Description Summary**: The Specialist, Medical Affairs for Post-Market Surveillance (SMA-PMS) for Specimen Management (SM), Medical Affairs (SA) is responsible for post-market reporting compliance activities. This position is accountable for coordinating and contributing to the SM post market surveillance reports and ensuring alignment with US, EU,...
-
Regulatory Manager
1 week ago
Miami, United States CRO Strategies Full timeAs the Regulatory Manager, you will be responsible for ensuring that all regulatory aspects of clinical research trials conducted at our site are managed effectively and in accordance with federal and state regulations, institutional policies, and study sponsor requirements. You will work closely with the clinical research team, Institutional Review Boards...
-
Regulatory Manager
3 days ago
Miami, United States CRO Strategies Full timeAs the Regulatory Manager, you will be responsible for ensuring that all regulatory aspects of clinical research trials conducted at our site are managed effectively and in accordance with federal and state regulations, institutional policies, and study sponsor requirements. You will work closely with the clinical research team, Institutional Review Boards...
-
Sr. RCM Specialist
2 weeks ago
Miami, United States Capstone Copper Corp. Full timeSR. RCM Specialist Reporting to the Superintendent of Assets & Engineering, the Sr. RCM Specialist will be responsible for ensuring the condition monitoring team has the proper guidance and resources to effectively monitor asset health and improve maintenance programs at Pinto Valley. Although primarily a leadership role ensuring prioritization and...
-
Sr. RCM Specialist
2 weeks ago
Miami, United States Capstone Mining Full timeSR. RCM SpecialistReporting to the Superintendent of Assets & Engineering, the Sr. RCM Specialist will be responsible for ensuring the condition monitoring team has the proper guidance and resources to effectively monitor asset health and improve maintenance programs at Pinto Valley. Although primarily a leadership role ensuring prioritization and...
-
Senior Legal Counsel, Regulatory Gov
3 weeks ago
Miami, Florida, United States Taylor Root Full timeOur client is seeking a Senior Regulatory Governance and Compliance Legal Counsel to join their Legal and Compliance team in Miami, FL.The candidate will handle all matters concerning regulatory governance, in particular in relation to FIFA statutes and the FIFA governance regulations due to the companies close work with the FIFA...
-
Senior Legal Counsel, Regulatory Gov
3 weeks ago
Miami, United States Taylor Root Full timeOur client is seeking a Senior Regulatory Governance and Compliance Legal Counsel to join their Legal and Compliance team in Miami, FL. The candidate will handle all matters concerning regulatory governance, in particular in relation to FIFA statutes and the FIFA governance regulations due to the companies close work with the FIFA...
-
Post Closing Specialist
4 weeks ago
Miami Lakes, United States Highly Regarded Title Agency Full timeJob DescriptionJob DescriptionWe’re hiring a Post Closing Specialist to work in our post closing department. As a member of the post closing team, you’ll assist the department with the finalizing of the documents, quality control review, and document processing and recording. The ideal candidate for this position balances post-closing duties, such as...
-
Training Specialist
4 weeks ago
Miami, United States Joint Activities Full timeSummary About the Position: As a Training Specialist (Joint Concepts), you will advocate for joint concept development, testing, wargaming, and implementation; AND support USSOUTHCOM Joint Lessons Learned Program, training assessments, Joint Training Plans, and joint doctrine collaboration and updates. This position is located at the Exercises and...
-
Clinical Lab Specialist
2 weeks ago
Franklin Lakes, United States MILLENNIUMSOFT Full timeHello There, We at Millenniumsoft looking for Clinical Lab Specialist & Clinical Lab Assistant /Sample Processor with5 years’+ experience in clinical laboratory science or in clinical research, product investigations, troubleshooting abnormal laboratory results and product development with clinical trials’ experience desired. Job Title – Clinical...
-
Customer Svcs Specialist Sr
1 week ago
Detroit Lakes, United States The State of MN Full timeThis position exists to work with the Associate Directors of Financial Aid, under minimal supervision, to assist and support new students and their parents/guardians in educating, accessing and engaging in the financial aid application process. Job d Customer, Specialist, Financial, Student, HR, Retail, Process
-
Reliability CM Specialist
4 weeks ago
Miami, United States Capstone Mining Full timeJob DescriptionJob DescriptionPOSITION PURPOSEReporting to the Sr. RCM Specialist in the Assets & Engineering Department, the specialist will be responsible for retrieving, documenting, and organizing information for the maintenance reliability programs and activities of Pinto Valley. The specialist will focus on the identification of maintenance related...
-
IT Specialist
6 days ago
Miami, United States National Oceanic And Atmospheric Administration Full timeAs an IT Specialist, you will perform the following duties: Install and upgrade the servers and application tools in Oracle and Microsoft SQL database environments. Allocating system storage and planning future storage requirements for the database systems. Creating primary database storage structures (tablespaces) and primary objects (tables, views,...
-
Training Coordinator
1 month ago
Miami, United States Capstone Mining Full time**POSITION PURPOSE** **REPORTING TO**: Sr. Training Specialist **COLLABORATING WITH** (Key Departments, External Groups): Internal: - Leaders including Managers, Superintendents, Sr. Coordinators, and Frontline Supervisors - Subject Matter Experts (SME) - Employees External: - Contractors, Consultants, and Vendors - Professional & Industry...