Associate Regulatory Affairs Manager (San Diego)

Who is CorDx？     CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.     Job Type: Full time   Job Title: Regulatory & Compliance Specialist Location: Onsite - San Diego Salary Range: $90,000 - $95,000 Position Summary: The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. This role will work closely with cross-functional teams to support product development, manufacturing, and post-market activities. The specialist will ensure that all documentation and files related to diagnostic development are completed in a timely manner and are ready for inspections. Key Responsibilities: Ensure compliance with regulatory requirements for In Vitro Diagnostic products, FDA 21 CFR Part 820, ISO 13485. Provide regulatory guidance during the product development process, ensuring that products are designed and developed in compliance with applicable regulations. Participate in risk management activities, including the development and maintenance of risk management files according to ISO 14971 and FDA 21 CFR Part 820. Conduct risk assessments and work with product development teams to mitigate identified risks. Participate in design reviews meetings and validation activities, ensuring that regulatory and quality requirements are met. Review and approve design control documentation, including design input and output, design verification and validation protocols, ensuring that all documentation meets regulatory requirements. Review and approve design history file for each new product. Support preparation of internal quality and regulatory documents in support of regulatory submission (De Novo and 510K) for IVD products. Requirements Education: Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs, Quality Management) or equivalent experience. Advanced degree or certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., CQE, CQA) is a plus. Experience: 3+ years of experience in regulatory affairs, quality assurance, or compliance within the medical device or In Vitro Diagnostics industry. Experience with regulatory submissions, including 510(k) and CE marking, is highly preferred. Strong knowledge of global regulatory standards, including FDA regulations and ISO 13485. Skills: Strong understanding of IVD product development and manufacturing processes. Excellent written and verbal communication skills Strong analytical and problem-solving skills, with attention to detail and accuracy. Ability to work independently and as part of a team, with strong organizational and time-management skills. High level of integrity and commitment to upholding regulatory and quality standards. Proactive approach to identifying and addressing compliance risks and issues. Benefits Medical Insurance Plan Retirement Plan Paid Time Off Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.  

INDEPENDENT CONTRACTORS NEEDED. THIS IS AN INDEPENDENT CONTRACTOR OPPORTUNITY Looking for a way to make some extra money, can you use an extra $400 to $700 every two weeks? Good profits for a few hours per morning. Wonderful way to supplement your current income. A great business opportunity. Be your own boss. Fee based contract available for individuals with the following requirements: 1. Valid driver License. 2. Social Security Card. 3. A good 3-year DMV report. 4. Your current car insurance. 5. Reliable vehicle We will consider you for paper routes available in your zip code and any zip codes around you. ALL PAPER ROUTES ARE DELIVERED 7 DAYS A WEEK BETWEEN 12:30 TO 6:00 AM. ROUTES ARE AVAILABLE TO START RIGHT AWAY. Sign on bonus - $100.00 every agent fee period that you stay on the route (Max total $500.00) Offer good for July 2nd, 2025, thru September 30th, 2025 If interested, please email or text us at: route@reviewjournal.com Please include your first & last name, zip code, and phone number when you reply.

Who is CorDx？     CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.     Job Type: Full time   Job Title: Associate Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position Summary: The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulatory projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle. Key Responsibilities: Assist in the preparation, review, and submission of regulatory documentation for new products, product changes, and ongoing compliance. Support the regulatory submission process for 510(k), Technical Files, and other regulatory filings. Provide regulatory guidance to cross-functional teams during product development and post-market activities under the direction of senior management. Help track and manage submission timelines, regulatory project plans, and documentation. Stay informed on changes in FDA, ISO 13485, IVDR, and other global regulations, communicating relevant updates to the team. Conduct regulatory assessments for product modifications and assist in defining appropriate submission strategies. Participate in internal and external audits, inspections, and regulatory agency communications as assigned. Contribute to the maintenance of regulatory files and submission records in accordance with internal procedures and regulations. May provide oversight and mentorship to junior staff or specialists on assigned projects. Requirements Education: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field. Master’s degree preferred. Professional Experience: 4–6 years of regulatory affairs experience in the medical device or IVD industry. Experience supporting or managing 510(k) submissions and regulatory filings. Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and international medical device regulations. Experience participating in regulatory audits and inspections preferred. Skills & Competencies: Strong organizational, document management, and project coordination skills. Excellent communication, problem-solving, and cross-functional collaboration abilities. Detail-oriented with the ability to manage multiple regulatory projects and priorities. Proficient in Microsoft Office and regulatory document management systems. Ability to work independently and proactively while seeking guidance for complex issues. Benefits Highly competitive compensation package. Comprehensive medical, dental, and vision insurance. 401(k) plan with generous company contributions. Flexible paid time off (PTO) policy. Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Ardwin Freight We Are Hiring Owner Operators Earn up to $30,000 before deductions per month. Join the fleet of Ardwin Freight We have 37 years of experience in the transportation business and are one of the most respected companies in California. We are ready to get you working quickly with our authorities and permits. Instead of waiting weeks and spending thousands of dollars obtaining permits and insurance, join Ardwin Freight and start working in just a few days. As an Owner Operator with Ardwin Freight, you will have access to dedicated loads and full support from the company's operations team to maximize your earnings while you focus solely on driving. What we offer includes: Permits and Authorities MC Number for interstate operations MCP Number for operations within California only USDOT - General Transportation Registration IFTA Permit Oregon and New Mexico Permits Oregon PUC Bond (surety deposit) UCR - Unified Carrier Registration. Annual payment. BOC-3 Process Agents - Annual Payment. Insurance and Regulatory Compliance Liability and Cargo Insurance Passenger Insurance Physical Damage Insurance for your truck. Join before March 31st and we cover your first year of Physical Damage! Drug and Alcohol Program Administration (Consortium) 90-day inspections and BIT inspection (every 2 years) Other Benefits Free parking Plates for all 48 states Electronic Logging Device (ELD), GPS, and security camera for driving 24/7 dispatch Fuel Discount Card Weekly payments and advances Equipment Financing Options* Why Choose Ardwin Freight? Earn up to $30,000 before deductions per month with dedicated and reliable loads. Save time and money by avoiding the costs of obtaining permits and insurance. Join a professional team that values and supports drivers. Focus on driving with peace of mind, knowing we handle regulatory compliance and securing loads for you. Your Responsibilities: Maintain your truck in good condition and compliant with safety standards. Fuel expenses (our discount card will help you save significant money!). Comply with federal and state regulations as an Owner Operator. At Ardwin Freight, we take pride in offering a fast and reliable way to get on the road and start earning money without delay. Join Today! Call us at: (800) 927-8153 Visit us: 2940 N Hollywood Way, Burbank, CA 91505 Bonus: Join before March 31st and we will cover the first year of your truck's Physical Damage Insurance. Stop wasting time and money on permits and insurance. Start earning what you deserve with Ardwin Freight today. Let’s hit the road together!

Professional Civil Process (PCP) is looking for an Accounts Payable Clerk – a person who wants to go above and beyond for the legal support industry. We’re looking for someone with exceptional energy and enthusiasm to join our Accounting Team. About PCP: PCP is the leader in the legal support industry providing filing, serving, and skip tracing services. We've been serving the legal community for over thirty-five years. PCP currently handles over 140,000 services of process documents annually. Our corporate headquarters is in Spicewood, Texas with 22 offices throughout the state of Texas. PCP is a founding member of the National Association of Professional Process Servers (NAPPS) and the Texas Process Servers Association (TPSA). About the position: Review and process expense report Review and pay vendor invoices Submit payment of company bills Reach out to service providers about getting a lower rate Any other duties given by Accounting Supervisor Requirements About you: High school diploma or equivalent. Two (2) years of accounting experience Strong attention to accuracy and detail Organizational skills Flawless attendance Typing skills (40 wpm/10-key touch) - test will be given Basic computer skills - Microsoft Excel and Quickbooks experience preferred! Effective multi-tasking skills Excellent customer service and written & verbal skills Accuracy in grammar and spelling Commitment to team results; a team player, but can work alone Benefits Compensation, Hours, and Benefits: Pay: $16.00 per hour Full-Time: Monday – Friday, 8:00a – 5:00p Dental/vision plan - available upon hire MEC Health Plan - "Minimum Essential Coverage" - Preventative Care only - after 60 days of service Ten (10) paid holidays per calendar year - after six (6) months of service Paid Time Off (PTO) – after six (6) months of service 401k savings plan – after one (1) year of service Casual/laid back work environment Gym

We are seeking a dedicated and experienced Dry Cleaners Customer Service Representative. The role involves providing exceptional customer service, ensuring accurate tracking of orders, and maintaining a professional appearance. Qualifications: • Minimum of 3 years' experience in Dry Cleaners operations, customer service, or a related supervisory role. • High school diploma or equivalent; a degree in Business Administration or a related field is a plus. • Proficiency in MS Office and retail management software. • MUST pass comprehensive background check prior to employment.