Overnight Stocking Associate

We are seeking a dedicated and knowledgeable Regulatory CMC Technical Associate to join our team in Bridgewater, NJ. In this pivotal role, you will support the development and maintenance of regulatory submissions, with a focus on chemistry, manufacturing, and controls (CMC) documentation. Your expertise will be crucial in ensuring compliance with regulatory…

We are seeking a dedicated and experienced Regulatory Affairs Specialist III to join our team in Bridgewater, NJ. In this pivotal role, you will be responsible for ensuring compliance with regulatory requirements and managing submissions to various health authorities.Your expertise will play a vital role in supporting the development and marketing of pharmaceutical products. You will collaborate with cross-functional teams to prepare and submit regulatory documents, analyze regulatory changes, and ensure adherence to industry standards.

We are seeking a highly skilled Regulatory Publishing Manager to join our dynamic team at Artech Information Systems LLC. The ideal candidate will possess extensive experience in regulatory publishing and will be responsible for overseeing the preparation and submission of regulatory documents. This role demands a detail-oriented individual who can ensure compliance with regulatory standards while managing project timelines effectively.

Join our dynamic team as a Regulatory Affairs Specialist-V and play a pivotal role in ensuring compliance with regulatory standards in the pharmaceutical industry. You will be responsible for managing regulatory submissions, liaising with regulatory agencies, and ensuring that our products meet all necessary guidelines.

About Spectrum VascularSpectrum Vascular is a pioneering medical device firm dedicated to enhancing vascular access and medication management. Our mission is to improve patient outcomes globally by equipping caregivers with high-quality, innovative products and exceptional customer service. Formed through the integration of a trusted portfolio of widely used products, innovation remains a strategic pillar of our journey. Our designs focus on delivering antimicrobial and antithrombogenic protection, catering to critical care and pediatric patient needs. This role offers a unique chance to join a dynamic team with established products and an entrepreneurial spirit.Role Overview:The Regulatory Affairs Specialist plays a crucial role in supporting global regulatory submissions and ensuring compliance for medical device products throughout their lifecycle. This position requires collaboration with Quality, Engineering, Clinical, and Manufacturing teams to effectively prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation, Health Canada, and other global filings).Maintain regulatory files, declarations of conformity, and device registrations.Respond to regulatory agency requests for additional information (AIs, deficiency letters, technical queries).Support U.S. and EU market approval processes, ensuring adherence to regulatory standards.Assist with post-market submissions (progress reports, annual reports, etc.).Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers.Communicate with distributors concerning information requests, regulatory inquiries, and support for regulatory filings.Compliance & Quality System SupportCollaborate with Quality Assurance to maintain compliance with relevant regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.Participate in internal audits, management reviews, and preparations for external audits as necessary.

About Spectrum Vascular Spectrum Vascular is a pioneering medical device organization dedicated to enhancing vascular access and medication management. Our mission is to elevate patient care globally by equipping caregivers with high-quality, innovative products and unparalleled customer support. Established through the acquisition of a portfolio of trusted products utilized by healthcare professionals for decades, we prioritize innovation at the core of our strategy. Many of our offerings are designed to provide antimicrobial and antithrombogenic protection, catering specifically to critical and pediatric patient populations. This position offers a unique chance to join a vibrant and expanding team with established products and an entrepreneurial spirit. Role Overview: As a Regulatory Affairs Manager, you will be a key player in developing and executing regulatory strategies focused on achieving product registrations and ensuring compliance with product claims across both current and new submissions in the U.S. and internationally. This role involves overseeing the creation and submission of regulatory documents to maintain compliance for our existing product line as well as new products. Key Responsibilities: Serve as a primary liaison for regulatory affairs on cross-functional product development and post-marketing teams, supporting submission initiatives throughout the product lifecycle. Independently manage tasks to facilitate the market introduction of medical devices while ensuring ongoing regulatory compliance. Collaborate on cross-functional teams to devise U.S. and global regulatory strategies. Draft regulatory submissions, engage with regulatory agencies and notified bodies, review labeling and marketing materials, and analyze proposed changes to devices. Utilize regulatory intelligence to shape local, regional, and global strategies, while independently assessing regulatory issues and updating technical documentation as needed. Proactively identify and address regulatory challenges and emerging issues throughout the product lifecycle, developing effective solutions. Provide regulatory insight and technical support for product development and planning throughout the product lifecycle. Evaluate the adequacy of quality, preclinical, and clinical documents for regulatory submissions to ensure compliance. Review proposed changes relevant to regulatory submissions and communicate necessary adjustments.

We are seeking a Senior Technical Writer to join our dynamic team at Integrated Resources, Inc. In this pivotal role, you will be responsible for producing high-quality documentation that contributes to the overall success of our projects. You will collaborate with engineers, product managers, and other stakeholders to create user manuals, installation guides, and online help documentation.The ideal candidate will possess excellent writing skills, a strong grasp of technical concepts, and the ability to communicate complex information clearly and effectively. Join us in making technology accessible and understandable!

We are seeking a dynamic and experienced Associate Director to join our team at Integrated Resources, Inc. In this pivotal role, you will lead strategic initiatives, drive operational excellence, and foster a culture of innovation. As an Associate Director, your leadership will be crucial in guiding our teams to achieve their goals and contribute to the overall success of the organization.

Join our dynamic team as a Part-Time Retail Merchandising Associate! In this role, you will be responsible for enhancing the shopper's experience through effective merchandising and product placement. Your keen eye for detail and passion for retail will ensure that our products are presented in an appealing manner, driving sales and customer satisfaction.

Step into the most vibrant store in the mall! At BoxLunch, we're on the hunt for passionate music and pop culture enthusiasts eager to enhance our customers' shopping experience. As a Sales Associate, you'll play a vital role in our success by delivering exceptional customer service, ensuring that fellow fans find the merchandise they adore. Utilize your fandom knowledge while restocking and organizing products, and help us create an engaging store display that captivates our audience—all while prioritizing an outstanding in-store experience.

Alo Yoga is hiring a Full-Time Sales Associate for the Bridgewater Commons store in Bridgewater, NJ. This position centers on supporting customers with their yoga apparel choices and sharing the brand’s focus on health and mindfulness. Role overview Sales Associates help shoppers discover products that fit their needs, answer questions about styles and features, and ensure each person feels welcome in the store. This role involves working on the sales floor, engaging with customers, and maintaining a positive atmosphere that reflects Alo Yoga’s commitment to wellness. What you will do Deliver friendly, attentive service to every customer Assist clients in selecting yoga and wellness apparel Promote the values of health, mindfulness, and an active lifestyle What we’re looking for Enthusiasm for yoga, wellness, and retail Strong communication and interpersonal skills Comfort working as part of a team in a retail setting

Join Integrated Resources Inc. as a Signal Detection and Drug Safety Associate II, where you will play a pivotal role in ensuring the safety and efficacy of pharmaceutical products. In this position, you will collaborate with cross-functional teams to assess and analyze safety data, contribute to signal detection activities, and help maintain compliance with regulatory requirements.