Description. The Regulatory Affairs Specialist is responsible for identifying, evaluating, and ensuring compliance with all applicable laws, regulations, and standards. The Regulatory Affairs Specialist shall also conduct reviews of all and all future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and a...
This job offer is not available in your country. New Product Development 60%. Act as Subject Matter Expert (SME) and Regulatory Affairs lead for the new product development projects, provide "solution-based" advice to development teams. Develop and maintain regulatory strategies for new and modified product / product families. Prepare and execute regulatory filings such as pre-IDEs, premarket notifications, technical files, Canadian submissions, ...
This job offer is not available in your country. Position Summary. The Senior Regulatory Affairs Specialist will be responsible for performing a wide variety of tasks to. ensure global compliance with all cosmetic and OTC regulatory requirements. This position will be. responsible for supporting global regulatory programs and strategies by working collaboratively with. his / her supervisor and key business partners. He / she will support new & ex...
IMMEDIATE OPENING FOR REGULATORY SPECIALIST- ONSITE. This role involves preparing documentation to support international product registration, maintaining registration files and electronic databases. It requires preparing documents for notarization, legalization, and shipping, as well as tracking documents needed for product registrations within the company's regulatory framework. The position entails participating in inspections and audits condu...
ISG is recruiting for a local leading medical device company in. Norfolk, Virginia. they are dedicated to improving healthcare outcomes through innovative products. As a company committed to quality and compliance, they are seeking a talented. Regulatory Affairs Specialist. to join the team and oversee the. 510(k). submission process to the FDA. Job Description. As a Regulatory Affairs Specialist, you will play a critical role in ensuring complia...
ISG is recruiting for a local leading medical device company in. Norfolk, Virginia. they are dedicated to improving healthcare outcomes through innovative products. As a company committed to quality and compliance, they are seeking a talented. Regulatory Affairs Specialist. to join the team and oversee the. 510(k). submission process to the FDA. Job Description. As a Regulatory Affairs Specialist, you will play a critical role in ensuring complia...
Description. . Managing the preparation of regulatory submissions for IND ANDA NDA 510K AdProm and other electronic submission types. o Creating timelines for regulatory filings. o Providing and maintain templates for authoring. o Overseeing authoring and reviewing of regulatory documents. o QC submission documents. Contribute to the development of process improvements and procedural documents. Identifying and assessing regulatory risks and risks...
Hologic is seeking a. Regulatory Affairs Specialist. to join our expanding Innovation Center located in Newark, DE. . . What to Expect. . The. Regulatory Affairs Specialist. is expected to perform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company ...
Regulatory Affairs Specialist. Onsite in St. Louis MO (3 days onsite, 2 remote). 2 positions to fill. Pay: $30.00-$34.00 an hour based on experience. 2 year contract opportunity to hire opportunity. Must have experience in regulatory affairs in medical devices. Experience writting technical files. Bachelors degree required. Your Role. With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory tasks related...
This job offer is not available in your country. Job Description. One of our top clients is recruiting again. They are looking for a Regulatory Affairs Specialist for their facility. Interested job seekers should have work experience with a highly successful and well-established medical device manufacturer. An overview of the Regulatory Affairs Specialist's responsibilities. 1) Be responsible for international regulatory submissions and regulator...
About CooperSurgical. CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medi...
Job Summary. We are seeking a highly skilled and detail-oriented Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with all relevant regulations and guidelines in the pharmaceutical industry. Your expertise in clinical trials, research, and FDA regulations will be essential in supporting our company's mission to deliver safe and effective products to our customers. ...
