What does a Senior Regulatory Affairs Specialist Do?
The Senior Regulatory Affairs Specialist assists in developing procedures to ensure regulatory compliance. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Being a Senior Regulatory Affairs Specialist typically reports to a manager or head of a unit/department. May require an advanced degree. Working as a Senior Regulatory Affairs Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally indepe ...ndent and collaborative in nature.More Show Less
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Job Purpose/ Summary. Independently manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist, and advise study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of ...
Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes. Summary Description. Under minimal supervision: Provides independent regulatory guidance to product development and life-c...
Company Description. A Few Words About Us. Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT...
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. . JOB DESCRIPTION. Working at Abbott. At Abbott, you can do work that matters, grow, and learn, care...
Salary: $ 150,000.00. We have partnered with a large medical equipment company in the Irvine, CA area to provide them with a Senior Regulatory Affairs Specialist. Please review the below description and let us know if you are interested. Prioritized Must Have Skills for the Senior Regulatory Affairs Specialist. 1. Bachelor's degree or higher in Life Sciences, Engineering, or related disciplines. 2. Minimum of 5 years' plus experience in Regulator...
Visual Pak Companies is an Equal Opportunity Employer. Visual Pak does not discriminate on the basis of race, color, religion, marital status, age, national origin, disability, medical condition, pregnancy, gender (orientation or identification), sexual orientation, veteran status, or any other basis covered by federal, state, or local laws. All employment decisions are based on qualifications, merit, skills, individual performance, and business ...
. Sr. Regulatory Affairs Specialist. . Locations. Sunnyvale, CA. Job Type. On-site, FTE. . Salary Range. 80K-140K. Responsibilities. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis and implement and maintain ...
Acara Solutions is looking for a Sr. Regulatory Affairs Specialist with. medical device experience. in Brea, CA. This position is a contract position lasting 6-8 months. Pay: $45 hourly. Hybrid schedule (onsite 3 days a week). This person needs to be a Regulatory Lead on New Product Development cross-functional teams (i.e. helping new products and/or changes to existing products launch into market having met all compliance and design control requ...
Job Details. Job Location. Remote - Remote1, OH. Position Type. Full Time. Education Level. Bachelor's Degree. Salary Range. Undisclosed. Travel Percentage. None. Job Shift. Standard Business Hours. Job Category. Other. Description. Tosoh Bioscience, Inc., based in South San Francisco, CA is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Established in the United States in 1989, Tosoh Bioscience has b...
Job Title. Senior Regulatory Affairs Specialist. Location. Princeton, NJ. Job Description. Regulatory Submissions: Compile, prepare, and review US 510k submissions and EU IVDR Technical Files to ensure compliance with applicable regulations. Regulatory Strategy: Anticipate and navigate regulatory obstacles throughout the product submission cycle, collaborating with regulatory and cross-functional teams to develop effective solutions. Lifecycle Pl...
Responsible for compiling and maintaining US 510k submission and EU IVDR Technical File.Responsible for compliance with applicable Corporate and Divisional Policies and proceduresunder the quality system. Core Job Responsibilities For This Role May Include. Compile, prepare, and review regulatory submission to US and EU. Anticipate regulatory obstacles and emerging issues throughout the product submissioncycle and develop solutions with other mem...
