Responsibilities Member of the international RA team and responsible for preparing and providing documents for registering assays and complementary products worldwide and collaborating with marketing in market expansion projects. Assists in the preparation of regulatory submission dossiers for assays in the Laboratory Diagnostics product portfolio with key focus on Clinical Chemistry and Immulite portfolio. Participates in meetings to review market expansions / compliance requests for Siemens an...

Siemens Healthineers is building tomorrow’s talent. Change the future with us. We are looking for dedicated and talented people who tackle ever-changing challenges, customer needs, and questions from colleagues with clever concepts and creativity.  We embrace change and work with curious minds re-inventing the future of work.  Join us and let us focus together on what’s truly important: making lives better with new ideas and the latest technology around the world. Why you’ll love working for Sie...

Abbott is a global healthcare company committed to helping people live not just longer, but better. We employ around 99,000 people in 150 countries with a diverse portfolio spanning pharmaceuticals, nutrition, diagnostics and devices. Across our office in Heerlen we continue to innovate and to solve complex challenges within the healthcare industry while planning exciting developments that lie ahead. At the moment we are looking for a Regulatory Affairs Specialist to join us on a full-time basis...

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com ...

Corindus, A Siemens Healthineers Company is a global technology leader in robotic-assisted vascular interventions. The company's CorPath® system is the first FDA-cleared medical device to bring robotic-assisted precision to percutaneous coronary and peripheral interventions. Corindus is advancing the field of interventional medicine with robotics through improvements to procedural control, precision, and workflow. Now’s our time to inspire the future of healthcare together. At Siemens Healthinee...

Career Category Regulatory Job Description The Local Regulatory Representative (Manager) is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s) in their country(ies). The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen. Assist in aligning local regulatory requirements with Amgen’s corporate standards. Provide local input to and execute regulatory strategies. Plan and manage local regulatory submiss...

Career Category Regulatory Job Description To lead the dossier preparation and submission to agency for all kinds of application (CTN/MAA/variation/notification/annual report) and ensure the submission of target. Filing and submission: Lead submission in partnership with TA team Coordinate and follow the dossier package preparation with CMC team and cross-functions Analyze the gaps and needs for China RA in early phase submission Arrange dossier package printing and binding to ensure the submiss...

Career Category Regulatory Job Description Amgen is seeking a Regulatory Affairs Manager (CMC). The Regulatory Affairs Manager will work out of the site in Cambridge MA, or our main corporate campus in Thousand Oaks, CA, or remotely. The Regulatory Affairs Manager will assume a Global regulatory CMC lead role for early development clinical programs.  Responsibilities will include the development of regulatory strategy for filing across multiple jurisdictions and communication of requirements and...

Career Category Regulatory Job Description Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines. Today, serving millions of patients, Amgen continues to be an entre...

Career Category Regulatory Job Description The Amgen Capability Center in Lisbon, Portugal (ACCP) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross functional capabilities, including Commercial, General and Administrative, Research and Development and more. The ACCP will offer rich career growth and development opportunities, regional and global exposure and the opportunity to LIVE, WIN and THRIVE in one of Europe’s most attractive cities. ...

JOB TITLE: REGULATORY AFFAIRS DIRECTOR CAREER LEVEL: F Leverage technology to impact patients and ultimately save lives Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you! ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the d...

Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaning...

About us At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a biopharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet ...

Job Title: Director, Global Regulatory Affairs Position Location: Global Role – located in Uppsala, Sweden Position Summary: Director of Global Regulatory Affairs, IDD, is responsible for leading the activities of the global regulatory team with emphasis on regulatory strategy and the preparation, review and submission of documents to regulatory authorities globally. The Director Regulatory Affairs is required to combine knowledge of scientific, regulatory and business issues to enable products ...

Job Title: Regulatory Affairs Manager Requisition ID:   118166BR   When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world .   Location/Division Specific Information Petaluma or San Diego, California   How will yo...

null In this role, you have the opportunity to Provide input for regulatory strategy during the product creation process and contribute to the department’s overall regulatory strategy plan. You are responsible for Developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategy Planning, coordination and preparation of document packages for regulatory submissions ...

null Starting Date: June Duration: at least 6 months In this role you have the opportunity to: Support the Regulatory Affairs (RA) team for EU Medical Device Regulation (MDR) international in their daily tasks for product registrations and portfolio readiness. You are responsible for: Creating EU MDR trackers for products portfolio in international and keeping the documents updated Ensuring group newsletter information collection is collected and dispatched on a monthly basis to the team Manage ...

null In this role, you have the opportunity to Provide Regulatory Affairs Support for New Product Development and Sustaining efforts in both the domestic and international markets for assigned medical devices. You will directly support registration and licensing in the US, Canada and EU and indirectly support the International Market groups for all other licensing. You are responsible for Working independently on the Regulatory duties, processes and roles outlined below: Supports and provides re...

null In this role, you have the opportunity to Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into the Peoples Republic of China. Communicates with relevant competent authorities, agents, distributors and local sales offices to ensure the most efficient path to application approval. Advise local and international teams on the most expedient route to obtaining product licenses, and ensure market access strategy is aligned with ...

null In this role, you have the opportunity to support and implement product regulatory plans, provide guidance on global regulatory strategy and product registrations, participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements and standards. You are responsible for Supporting the implementation of the Business’ long-range quality, regulatory and compliance policy Creating Q&R awareness level as determined within the organization...