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It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". Under the direction of Regulatory Affairs Management, this role independently leads regulatory assessments, develops strategy options, recommends compliant pathways, and advises leadership on regulatory risks, pathway options, and recommended approaches to support informed decision-making.

YEAR

Varian Medical Systems Inc

Senior Regulatory Affairs Specialist

Coordinates regulatory requests from Sales Offices and internal stakeholders, including Certificates to Foreign Governments (CFGs), Certificates of Free Sale, authentications, and other regulatory certificates or documentation. Ensures regulatory information for assigned products and markets is current and supports timely retrieval and presentation of documentation for internal stakeholders, regulatory authorities, audits, inspections, and other authorized requests.

Nihon Kohden OrangeMed Inc

Regulatory Affairs Specialist

This role is responsible for planning and executing regulatory submissions, maintaining product registrations, supporting regulatory compliance, and partnering with in-country representatives and cross-functional teams to help ensure timely market access and continued product availability. Advanced Bionics is seeking an International Regulatory Affairs Specialist to support regulatory strategies and activities for product approvals and registrations across Middle East and North Africa (MENA) markets.

Sonova Holding AG

Specialist I, Regulatory Affairs

This Valencia, CA-based role is responsible for helping obtain and maintain regulatory approvals, preparing local submissions, supporting in-country Regulatory Affairs representatives, assessing regulatory impact for product and process changes, and ensuring compliance with applicable pre-market and post-market requirements. Advanced Bionics is seeking a Senior Specialist, International Regulatory Affairs to support regulatory activities for Class III medical devices, with a primary focus on China and Taiwan market registrations.

Senior Specialist, International (China) Regulatory Affairs

With operations across four major business segments medical devices, nutritional products, diagnostics, and established pharmaceuticals the company employs biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals who collaborate across cross-functional, international teams. This global healthcare innovator has operated for more than 140 years, developing life-changing medical devices, diagnostics, nutritional science, and pharmaceutical products that reach patients in more than 160 countries.

HOUR

<p>Global Technical Talent is a subsidiary of Chenega Corporation (www.Chenega.com) with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. GTT has been a leader in the staffing industry for over 22 years and is one of the largest staffing firms in the New England region. We are known for our Fortune 500 clientele and cutting-edge, technology-driven recruiting infrastructure.</p>
<p>We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.<br> <br>There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: https://bit.ly/gttcareers <br> <br>Awards<br>SIA’s Best Staffing Firm to Work for ( 2019 -2023)<br>SIA’s Fastest Growing Staffing Firm<br>Inc 5000 Company<br>NH Business Magazines Fast 5 fastest growing companies.</p>

GTT, LLC

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Skills/Competencies: In-depth knowledge of FDA, EU MDR, and global medical device regulations, with experience preparing and maintaining regulatory submissions and technical documentation that support patient outcomes and regulatory excellence. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician training-supported by industry-leading clinical evidence.

Endologix LLC

Sr. Regulatory Affairs Specialist

Duties and Responsibilities: Prepare, review, and submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other relevant regulatory bodies and/or Distributors. 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.

Caldera Medical Inc

Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).

Glidewell Dental

Regulatory Affairs Specialist, Sr.

Your Role: As a Regulatory Affairs Specialist, you will be a key member of Elanco's Canadian Regulatory Affairs team, supporting the registration and lifecycle management of products across a diverse animal-health portfolio. Excellent written and oral communication skills, with the ability to coordinate cross-functional teams, represent Elanco in interactions with competent authorities, and maintain strong attention to detail in technical documentation.

Elanco Animal Health Incorporated

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Collaborate with subject matter experts to ensure regulatory submissions requirements are being met and technical and scientific data are incorporated into regulatory submissions, and collaborate with partners and local liaisons for management of submissions in foreign countries and facilitate meetings with SMEs as needed to track progress. Develop and execute submission strategies based on ability to understand complex technical information, and provide guidance to existing and new cross-functional product core teams for new product development and various on-market enhancements/changes from product concept to placing on the market.

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<h2>At Grifols, what we do matters</h2>
<p>Are you passionate about making a difference in the world? At Grifols, we are pioneers in the development of therapies derived from blood and plasma. We contribute to building the future of healthcare to improve people's well-being. Since 1909, we have been defined by passion, innovation, teamwork and a sense of responsibility. Our people change lives while growing and developing into a forward-looking international company.</p>
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<h2>Your future at Grifols</h2>
<p>At Grifols, you will be part of a growing international team of more than 23,000 people in more than 30 countries and regions with a common goal: to improve people's lives. You will contribute to developing scientific advances and providing innovative solutions for healthcare professionals and essential medicines for patients. We want to count on determined professionals who, by cultivating their talent, contribute to creating a positive impact on society.</p>
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Grifols

Regulatory Affairs Specialist 3 - Medical Device IVD

IRecruitee

OTHER

As a Regulatory Affairs Specialist III, you will help ensure critical diagnostic products meet global regulatory requirements, support product development initiatives, and maintain regulatory compliance across international markets. This role offers the chance to work with cross-functional teams, contribute to international regulatory submissions, and play a key role in bringing compliant healthcare solutions to markets around the world.

Manpower

Global Regulatory Affairs Specialist

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This individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.

Envista Holdings Corp

Regulatory Affairs Specialist II

This includes developing regulatory planning, preparing submissions, ensuring ongoing compliance with applicable regulations such as U.S. FDA and international market regulations, and supporting cross-functional teams to bring innovative solutions to market safely and efficiently. An employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs.

Beauty Health

Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)

Envista

Prepare, review, and submit regulatory documentation, including technical files, dossiers, device-change documentation, and letters to file. If you are a motivated and experienced Regulatory Affairs Specialist looking to make a significant impact in a cutting-edge industry, please apply today!

Lee Hecht Harrison

Remote Regulatory Affairs Specialist

Glidewell

Represent the Regulatory Affairs labeling function on project teams by collecting potential labeling inputs from other departments; interpreting the impact that projects, such as design changes, will have on labeling content; and implementing necessary modifications to the product labeling. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

Procept Biorobotics

Senior Regulatory Affairs Labeling Specialist

Regulatory Affairs Specialist manages assigned projects of moderate complexity which include international regulatory activities; on-market compliance reports or assessment of design changes, manufacturing process and labeling changes for regulatory reporting, as assigned. The Quality Engineer Level 4 - Risk Managementis a senior, highly experienced individual contributor responsible for leading complex risk management activities across the medical device and/or in-vitro diagnostic.

NextCare, Inc. Jobs in the United States

Senior Regulatory Affairs Specialist Varian Medical Systems Inc

Regulatory Affairs Specialist Nihon Kohden OrangeMed Inc

Specialist I, Regulatory Affairs Sonova Holding AG

Senior Specialist, International (China) Regulatory Affairs Sonova Holding AG

Senior Regulatory Affairs Specialist GTT, LLC

Sr. Regulatory Affairs Specialist Endologix LLC

Sr. Regulatory Affairs Specialist Caldera Medical Inc

Regulatory Affairs Specialist, Sr. Glidewell Dental

Regulatory Affairs Specialist Elanco Animal Health Incorporated

Regulatory Affairs Specialist 3 - Medical Device IVD Grifols

Global Regulatory Affairs Specialist Manpower

Regulatory Affairs Specialist II Envista Holdings Corp

Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA) Beauty Health

Regulatory Affairs Specialist Envista

Remote Regulatory Affairs Specialist Lee Hecht Harrison

Regulatory Affairs Specialist, Sr. Glidewell

Senior Regulatory Affairs Labeling Specialist Procept Biorobotics

Regulatory Affairs Specialist Hologic Inc

Senior Regulatory Affairs Labeling Specialist PROCEPT BioRobotics Corporation

Senior Regulatory Affairs Labeling Specialist Procept Biorobotics Corp

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