1,749 Customs Regulations jobs in the United States

We are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are passionate about regulatory affairs and looking for an opportunity to grow within a dynamic company, we encourage you to apply.

Responsibilities:

• Prepare, review, and submit regulatory documents to ensure compliance with FDA and other regulatory authorities.
• Maintain up-to-date knowledge of regulations, guidelines, and standards relevant to the pharmaceutical industry.
• Assist in the preparation of regulatory submissions including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and amendments.
• Coordinate with cross-functional teams to gather necessary information for regulatory submissions.
• Ensure timely and accurate communication with regulatory authorities.
• Monitor and track the progress of submissions and respond to any inquiries from regulatory bodies.
• Assist in the development and implementation of regulatory strategies to support product approvals and lifecycle management.
• Maintain accurate and organized regulatory files and records.

• Bachelor's degree in a related field such as biology, chemistry, or pharmaceutical sciences.
• Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred.
• Strong understanding of FDA regulations and guidelines.
• Excellent organizational and time management skills.
• Strong attention to detail and ability to handle multiple projects simultaneously.
• Effective communication skills, both written and verbal.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and as part of a team.

1 day ago Be among the first 25 applicants Dice is the leading career destination for tech experts at every stage of their careers. Our client, Cynet Systems, is seeking the following. Apply via Dice today! Job Description: Pay Range: $40.28hr - $5.28hr Responsibilities: Will introduce a new process to centralize post-approval addendum labeling activities for the full Vascular medical device portfolio. Experience: 3-5 years of experience, understanding quality, project management experience is plus, Addendum labeling is needed. (No fresh grads/ minimum of 3years experience) Experience in a regulated industry and experience in related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering and/or regulatory. Experience working with policies and procedures impacting documentation and documentation practices. Key Skills: Communication skills, cross-functional team, problem solver, SAP MD and other relevant software. Preferred Experience: Hands-on experience with addendum labeling and labeling requests and language requirements, which are critical for this position. (International experience is preferred) Strong knowledge of regulatory requirements for medical device labeling. Proficiency in SAP MD and other relevant software systems. Familiarity with Adobe Acrobat Pro, SAP, and other content management systems. Substantial experience coordinating and executing project activities in a highly regulated industry. Education: Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Legal Industries Software Development Referrals increase your chances of interviewing at Jobs via Dice by 2x Sign in to set job alerts for “Regulatory Affairs Associate” roles. San Jose, CA $80, 00.00- 90,000.00 4 months ago Santa Clara, CA 35.00- 39.00 21 hours ago Union City, CA 100,000.00- 120,000.00 1 week ago Regulatory Affairs Specialist - (NMPA/CFDA) Sunnyvale, CA 97,600.00- 165,200.00 2 days ago Santa Clara, CA 40.00- 45.00 18 hours ago Sunnyvale, CA 97,600.00- 165,200.00 2 days ago Regulatory Affairs Operations Specialist Santa Clara, CA 30.00- 40.00 17 hours ago Sunnyvale, CA 80,900.00- 128,800.00 1 week ago Health Transactional/Regulatory Associate San Francisco Bay Area 180,000.00- 200,000.00 20 hours ago Milpitas, CA 115,000.00- 150,000.00 1 day ago Sr Regulatory Affairs Specialist (Remote) - Shockwave Sr Regulatory Affairs Specialist (Remote) - Shockwave Santa Clara, CA 89,000.00- 165,600.00 8 hours ago Senior Regulatory Affairs Specialist - Vascular (on-site) Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave San Francisco Bay Area 60.00- 63.00 15 hours ago Senior Regulatory Affairs Specialist -Vascular (on-site) Regulatory Affairs Compliance Specialist - Pleasanton, CA Pleasanton, CA 115,000.00- 125,000.00 56 minutes ago Sr Regulatory Affairs Specialist - Shockwave Medical Senior Regulatory Affairs Specialist – Vascular (on-site) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Join to apply for the Regulatory Affairs Coordinator role at Counter 16 hours ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Coordinator role at Counter Description About Us: We are a startup revolutionizing beauty with a purpose; create the industry standard of “clean”. Our premium skincare, makeup, and body care formulations combine uncompromising safety, efficacy and environmental responsibility. And our vision transcends products. We are committed to inspiring confident women (and others) to recognize their collective power to create meaningful change. Our innovative community-commerce ecosystem connects customers, beauty enthusiasts, and loyalists, allowing each person to align with our brand in ways that authentically reflect their values and aspirations. From our formulas to our advocacy efforts to our community connection, we lead clean. In This Role You Will Assist with collecting thorough factual data & information to support the organization. Coordinate with various cross-functional teams and external partners to gather necessary and required information. Perform ingredient assessment based on current domestic and international regulations and standards. Review product promotional materials and labeling for compliance with applicable regulations. Assist in building and maintaining Regulatory Product Information File (PIF)/Product Dossier. Maintain accurate and up-to-date regulatory files and databases. Manage and track project timelines, ensuring that all regulatory deadlines are met. Track and report on the progress of all departmental projects in collaboration with various departments (Product Development, Safety, Quality, Packaging, Marketing, etc.). Provide support to internal stakeholders. Perform raw material and formula database data entry and validation. Stay up to date with relevant regulations and guidelines and provide guidance to the team as needed. Provide regulatory audit support as needed. Help drive process improvement for Regulatory Affairs (RA) department in support of continuous RA process improvement. Assist in communicating with Regulatory agencies and organizations. Perform other appropriate duties or tasks, as assigned by Supervisor Experience 2+ years of experience working in a regulatory department or directly related experience. With 1-2 years of scientific or technical discipline to perform data collection, extraction and analysis. Education Bachelor’s degree in Life Sciences, Law, Business Administration, or a related field (e.g., Chemistry, Biochemistry, Biology, or related science) Skills Must be proficient in Microsoft office, including Excel, PowerPoint and SharePoint. Ability to work to deadlines, set priorities and manage multiple projects simultaneously without compromising quality. Should be able to take notes in a meeting setting and be able to work in a fast-paced environment. Must take directions well and pay attention to detail with a high degree of accuracy. Strong interpersonal skills for collaboration with various departments within the company. Excellent communication, social, and interpersonal skills with the ability to collaborate cross-functionally Salary Description $75,000 Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Legal Industries Retail Referrals increase your chances of interviewing at Counter by 2x Get notified about new Regulatory Affairs Coordinator jobs in Santa Monica, CA . Santa Monica, CA $5,000.00- 75,000.00 2 weeks ago Los Angeles Metropolitan Area 75,000.00- 90,000.00 4 weeks ago Associate/Sr. Regulatory Affairs Associate Pasadena, CA 90,000.00- 120,000.00 2 weeks ago Los Angeles, CA 100,000.00- 150,000.00 3 hours ago Manager, Regulatory Affairs (MLR Coordinator) Pasadena, CA 150,000.00- 175,000.00 5 hours ago Burbank, CA 95,000.00- 135,000.00 2 hours ago Los Angeles, CA 112,000.00- 224,000.00 2 weeks ago Food Safety and Regulatory Affairs Manager San Fernando, CA 15,900.00- 224,000.00 3 weeks ago Los Angeles, CA 112,000.00- 224,000.00 2 weeks ago Vice President, Legal Affairs (Litigation, Regulatory & Public Policy) Bilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA Compliance We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Join to apply for the Regulatory Affairs Associate role at Riverpoint Medical Join to apply for the Regulatory Affairs Associate role at Riverpoint Medical Direct message the job poster from Riverpoint Medical Riverpoint Medical in Northeast Portland is hiring for Regulatory Affairs Associate II . We are hiring for a fully onsite position. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. As a full time, Regulatory Affairs Associate II you will : Support, prepare, and file regulatory submissions for approval, FDA 510(k), EU MDR/CE, and other international markets. Maintain Establishment Registrations, Device Listings and State Licenses both Domestic and International. Prepare and file regulatory notices and notifications for post market surveillance and vigilance. Collaborate with customers to create and maintain technical documentation for regulatory submissions. Generate annual medical device management review reports. Ensure the appropriateness of regulatory standards referenced within Quality System, maintain updated standard library and conduct GAP/risk analysis to determine impact of standard changes/revisions to comply with the state of the art . Review and approve Clinical Evaluation, Post-market Surveillance, and Post Market Clinical Follow-up reports. Review and approve domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conduct regulatory assessments for changes to marketed products. Review quality documents (operational procedures, work instructions, validations, etc.) including but not limited to protocols, for appropriate scientific rationale and for adherence to regulatory requirements/guidance, development strategy. Qualifications for this great opportunity include: Minimum 3-10 years knowledge and experience in Regulatory Affairs in the manufacture and distribution of sterile, disposable medical devices Certified ISO13485 auditor or equivalent job training Ability to create technical dossiers for customer regulatory submissions, experience with 510(k), MDR, Canada, Australia, or Brazil regulatory submissions. Experience with FDA QSR (21 CFR 820), MDR, and MDSAP requirements. Ability to interpret regulations, guidance and correctly apply them as appropriate in product development. Experience with Pre-Market and Post-Market regulatory support, including ISO10993, ISO14971, EN62366, ISO20417, ISO15223, Post Market Clinical Follow-up, Post Market Surveillance, Periodic Safety Update Reports (PSUR), Summary of Safety and Clinical Performance (SSCP), and Clinical Evaluations. Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval. Ability to review detailed scientific information and assess whether technical justifications are presented clearly and conclusions are adequately supported by data. Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks. Customer centric attitude, and experience with customer service is preferred. We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus! Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Seniority level Seniority level Associate Employment type Employment type Full-time Job function Job function Manufacturing Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Riverpoint Medical by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Disability insurance Get notified when a new job is posted. Sign in to set job alerts for “Regulatory Affairs Associate” roles. Portland, Oregon Metropolitan Area $69,000.00-$2,000.00 10 hours ago Regulatory Affairs Specialist (Food Manufacturing Experience) Manager/Senior Manager-Regulatory Affairs-West Portland, OR 125,000.00- 165,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Quality and regulatory affairs teams guard the safety of how a company operates and what it produces. Those who hold such positions have the opportunity to use their expertise for the good of others. At Danaher, quality and regulatory affairs jobs lead the way for a better tomorrow for humanity. We pioneer the future of science and technology to solve the world's most complex challenges. Our passion and dedication to this work bring a positive impact inside the company and all over the world. Maintain High Quality Standards A job in quality assurance or regulatory affairs means looking out for a company and the people it serves. In the scientific and health world, these jobs hold special significance. High quality means the right diagnosis or a successful medical procedure. The work focuses on meeting strict guidelines for safety and ethics. By following these regulations, quality and regulatory affairs teams ensure products work effectively. These products promote the safety of patients. In an international market, compliance professionals serve an even more significant role, navigating the complex and ever-changing rules of different countries to deliver consistent positive outcomes. Quality and regulatory affairs jobs also focus on keeping accurate records. These records clearly show how a company works, giving patients peace of mind. Advance Life-Changing Science and Technology Quality and regulatory affairs jobs at Danaher mean protecting customers and patients by providing innovative products that meet regulatory standards. As a company seeking to deliver innovation at the speed of life, we rely on regulatory experts. These professionals keep us improving and promote better results. A job in quality assurance or regulatory affairs means uniting teams under a common mindset and set of rules to create quality products that customers feel confident using. The work of these experts includes: Implementing quality management systems Overseeing adherence to applicable laws Establishing regulatory strategies Quality and regulatory affairs experts accomplish these tasks through audits, inspections and risk assessments. Their expert work accelerates ideas to impact by creating streamlined quality assurance processes. Danaher offers quality and regulatory affairs jobs around the world. We operate in countries like India, the United States, Sweden, Singapore and Germany. Over 15 operating companies within Danaher offer plenty of opportunities for advancing careers while making a difference in the world. The positions we offer range from intern and entry-level to specialist and management roles. Change the World With Danaher A career in quality and regulatory affairs at Danaher means unlocking access to innovation. Our jobs in this field mean watching out for quality in the work we do and the products we create, leading to positive impacts around the globe. A career at Danaher also provides individual benefits, including: Competitive benefits that care for physical, financial and emotional needs Career development opportunities through the Danaher Business System (DBS) A workplace that fosters diversity, equity and inclusion Explore Our Regulatory Affairs and Quality Assurance Jobs A job in quality assurance or regulatory affairs means looking out for a company and the people it serves. In the scientific and health world, these jobs hold special significance. High quality means the right diagnosis or a successful medical procedure. The work focuses on meeting strict guidelines for safety and ethics. By following these regulations, quality and regulatory affairs teams ensure products work effectively. These products promote the safety of patients. In an international market, compliance professionals serve an even more significant role, navigating the complex and ever-changing rules of different countries to deliver consistent positive outcomes. Quality and regulatory affairs jobs also focus on keeping accurate records. These records clearly show how a company works, giving patients peace of mind. Advance Life-Changing Science and Technology Quality and regulatory affairs jobs at Danaher mean protecting customers and patients by providing innovative products that meet regulatory standards. As a company seeking to deliver innovation at the speed of life, we rely on regulatory experts. These professionals keep us improving and promote better results. A job in quality assurance or regulatory affairs means uniting teams under a common mindset and set of rules to create quality products that customers feel confident using. The work of these experts includes: Implementing quality management systems Overseeing adherence to applicable laws Establishing regulatory strategies Quality and regulatory affairs experts accomplish these tasks through audits, inspections and risk assessments. Their expert work accelerates ideas to impact by creating streamlined quality assurance processes. Danaher offers quality and regulatory affairs jobs around the world. We operate in countries like India, the United States, Sweden, Singapore and Germany. Over 15 operating companies within Danaher offer plenty of opportunities for advancing careers while making a difference in the world. The positions we offer range from intern and entry-level to specialist and management roles. Change the World With Danaher A career in quality and regulatory affairs at Danaher means unlocking access to innovation. Our jobs in this field mean watching out for quality in the work we do and the products we create, leading to positive impacts around the globe. A career at Danaher also provides individual benefits, including: Competitive benefits that care for physical, financial and emotional needs Career development opportunities through the Danaher Business System (DBS) A workplace that fosters diversity, equity and inclusion Explore Our Regulatory Affairs and Quality Assurance Jobs Danaher is a world-leading innovator in science and technology. A job in regulatory affairs or quality assurance with us means advancing human health by meeting safety guidelines. Join our talent community to get tailored job recommendations based on your interests. Otherwise, view our open opportunities and apply for a chance to work together for a better tomorrow. #J-18808-Ljbffr