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Title: Regulatory Affairs Specialist Location: Mundelein, IL Duration: 3 to 6 Months Pay range: $25/hr to $30/hr Day-to-Day: Collabera is looking for an Adverse Event Specialist to review both new and historical product complaints to assess data completeness and determine MDR reportability. This individual will apply current regulatory guidance, decision trees, and internal procedures to evaluate adverse events and identify reportable malfunctions, injuries, or deaths. The specialist will prepa…
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Job Summary Under general supervision, the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. May review complex r…
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IKCON TECHNOLOGIES INC delivers exceptional IT services and solutions that provide clients with definite edge over competitors and promoting highest standards of quality. We are currently looking for a Regulatory Affairs Specialist with one of our clients in Remote, Remote . If you are actively looking for opportunities, please send us your updated resume with your contact details. JOB TITLE Regulatory Affairs Specialist/Senior Specialist for Drug-Device Combination Products CITY Remote STATE R…
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Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Regulatory Affairs Specialist . Job Description: Job Title: Regulatory Affairs Specialist Job Type: Contract Job Location: Sunnyvale, CA Work Schedule: On-site Pay Rate: $60, Based on experience Description: The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identifying applicable standards…
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Real Soft, Inc. Incorporated in 1991, Real Soft Inc. (RSI) is a US-based global software solutions company, a pioneer in providing professional services and delivering business solutions. You can learn more about our firm by going to: . Comments/Special Instructions This position is hybrid so the person must be local to Trumbull, CT. Wednesday and Thursday they will work in the Trumbull office. 3 days per week they will work from home Mon, Tues, Fri Occasionally once a month travel to Stamford,…
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Job Summary Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreem…
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Job Summary Job Description Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitm…
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Build your future with Volt! Volt is immediately hiring Senior Regulatory Affairs Specialist in Santa Clara, CA As a Regulatory Affairs Specialist, you will: Review product labeling, promotional materials, and marketing content for regulatory accuracy and compliance. Support integration activities by developing regulatory plans and strategies for acquired products and businesses. Prepare, compile, and submit regulatory documentation packages for new and existing products. Research and interpret…
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Represent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and possess a thorough knowledge of regulations for advertisement and promotional compliance governing device products (drug product experience acceptable) and the ability to translate regulatory requirements into decision-ready guidance for stakeholders. MUST have the education and experience to be able to review and conduct analysis independently in order to as…
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Our client, a global leader in consumer goods and chemical manufacturing, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs department supporting cross-functional product development and compliance teams. The ideal candidate will have strong analytical skills, excellent attention to detail, and effective communication skills which will align successfully in the organization. Job Title: Regulatory Affairs…
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Regulatory Affairs Specialist Marlborough, MA, United States San Diego, CA, United States At Hologic, women's health is at the heart of everything we do. Our Regulatory Affairs team plays a vital role in bringing innovative, compliant, and safe medical technologies to market, helping advance early detection, diagnosis, and treatment solutions that improve the lives of women around the world. Join Hologic's Regulatory Affairs team and help shape the future of women's health by navigating the pat…
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Join Stryker as a Regulatory Affairs Specialist in Portage, MI supporting Instruments - Surgical Technologies. This role will support regulatory activities for the Neptune Waste Management System, ensuring continued market access, compliance, and lifecycle management across global markets. You will partner with cross-functional teams to evaluate product changes, maintain regulatory approvals, and support strategic initiatives that enable ongoing commercialization, refurbishment, and expansion e…
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Regulatory Affairs Specialist In your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams you will ensure submissions are accurately prepared and comply with global regulations. The position is on-site and may require additional hours and/or travel as necessary to compl…
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Regulatory Affairs Specialist Date: Jun 26, 2026 Location: Maple Grove, MN, US Company: Teleflex Expected Travel : Up to 10% Requisition ID :14019 About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiol…
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Job Description - Ensure compliance of the chemical product portfolio during new product introduction and change management processes. - Conduct evaluations of chemical formulations to support regulatory compliance determinations. - Administer regulatory label and claims review processes. - Review supplier documentation, ingredient disclosures, and formulation data to verify accuracy and completeness. - Maintain regulatory profile data for commercial names and raw materials - Maintain positive …
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Stryker is hiring a Senior Regulatory Affairs Specialist to support Sports Medicine in Denver, CO or San Jose, CA ! In this role, you will develop and implement regulatory strategies, ensure compliance across the product lifecycle, manage regulatory submissions, advise stakeholders on regulatory requirements, and engage with regulatory authorities to resolve issues and support market access. What you will do: Develop and update regulatory strategies at the local, regional, and global levels by…
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Stryker is hiring a Senior Regulatory Affairs Specialist to support Sports Medicine in Denver, CO or San Jose, CA ! In this role, you will develop and implement regulatory strategies, ensure compliance across the product lifecycle, manage regulatory submissions, advise stakeholders on regulatory requirements, and engage with regulatory authorities to resolve issues and support market access. What you will do: Develop and update regulatory strategies at the local, regional, and global levels by…
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We anticipate the application window for this opening will close on - 11 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a…
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At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a fle…
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Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solu…
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