Responsibilities. The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards. The Regulatory Affairs position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo d...
Job Title: Regulatory Affairs Specialist. Job Description. We are seeking a full-time Clinical Research & Regulatory Affairs Specialist to work remotely for at least six months, dedicated to the oncology research program. This role involves preparing and processing all regulatory documentation through IRB/CIRB, including new submissions, continuing reviews, amendments, adverse events, and reportable events, with minimal supervision. The specialis...
POSITION SUMMARY. NRD, LLC seeks an early-career Regulatory Affairs Specialist who is eager to learn and ready to master the regulations that govern our nuclear materials manufacturing, distribution, transport, and exports. We are investing in a next-generation regulatory leader. This role is built as a growth path: you will start by executing well-defined tasks under mentorship, then progress to owning licensing actions, filings, and agency inte...
Join a fast-growing organization where you’ll be the go-to expert on food, beverage, and pet food regulatory compliance. Please note this position is located onsite in the Charlotte, NC metro. Position Overview. We’re seeking a detail-driven. Regulatory Affairs Associate. to support the Quality Assurance & Regulatory Affairs Director in maintaining compliance across the United States, Canada, and Mexico. This role plays a critical part in evaluat...
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As a Regulatory Affairs Specialist Consultant you will be responsible for. Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe, Asia). In collaboration with subject matter experts, independently prepare and author regulatory documents such as Design Dossiers, Technical Files, Device License Applications, Investigational Device ...
Job Description Summary. The Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product. The RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets. The RA Specialist is able to interpret and co...
At-a-Glance. Are you ready to build your career by joining a Multi-National Medtech Company. If so, our client is. hiring a Regulatory Affairs Specialist. Position Type. Contract. On-Site. Required. Bachelor’s degree in a scientific discipline required, Master’s degree or higher preferred. Minimum of 15 years’ experience in strategic Clinical and Regulatory Affairs tactical executions (including authoring regulatory submissions and demonstrating ...
Location : Newton MA 02466Shift : 8am-5pmResponsibilities :Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe, Asia).In collaboration with subject matter experts, independently prepare and author regulatory documents such as Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions (IDE),...
Overview. About You, As Our Ideal Candidate. Bachelor’s degree in Food Science, Nutrition, or a related field. 2–3 years of experience in regulatory compliance within the food industry. Experience with ingredient compliance, product compliance, claims, and labeling. Strong knowledge of FDA food regulations. Excellent organizational, analytical, and problem-solving skills. Strong written and verbal communication skills. Ability to work independent...
POSITION SUMMARY. Regulatory Affairs Specialist for APAC region responsible for all things Regulatory in the region, including but not limited to ingredient review, marketing collateral review, product registrations, and label reviews. Understands, implements, and maintains the regulatory policy. Ensures compliance to and demonstrates knowledge of site and division-level policies and procedures. SUPERVISORY RESPONSIBILITIES. This position has no ...
