- GRAIL (Olympia, WA)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For... device , or pharmaceutical industries is required. + Regulatory affairs and IVD device … more
- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Regulatory Affairs Director Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies, for...plans. + Act as the representative of the US regulatory team at the global regulatory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning considerations ... + Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device ... Device . + Demonstrated leadership in managing the global submission process for regulatory approvals across… more
- Teleflex (Wyomissing, PA)
- …assessments. - Basic experience working with cross-functional teams. Preferred: - Basic medical device global regulatory knowledge base (outside of the US, ... Sr. Regulatory Affairs Associate **Date:** Dec 23,...or medical technology. - Minimum 2 years of medical device regulatory experience or equivalent. - Basic… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in engineering or life sciences required. + Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 years ... more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports … more
- Olympus Corporation of the Americas (Westborough, MA)
- …BS or comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health industries. + Minimum ... of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will… more
- Lundbeck (Deerfield, IL)
- …Medical Affairs experience in the pharmaceutical, biotech or medical device industry. + Minimum 2+ years' experience with contribution to medical strategy ... Director Medical Affairs , Rare Epilepsies Evidence Generation Requisition ID: 7165...the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With… more
- FleishmanHillard (Washington, DC)
- …provides a fantastic opportunity to work at the intersection of healthcare and public affairs in service to pharmaceutical and medical device companies, as well ... desired areas of expertise include issues advocacy and public affairs campaigns, strong writing skills, and stakeholder engagement with...the best in-class counsel to our roster of remarkable global clients. Are you ready to join the team?… more
- Lundbeck (Deerfield, IL)
- …- open to candidates in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the ... + 10+ years of experience within a pharmaceutical, medical device and/or biotech industry, with 7+ years of experience...field. Doctorate Degree or MBA, other professional certifications. + Global Regulatory Affairs Experience. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …deliverables from assigned projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials for various ... Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs , etc. + Independent organizational and time management skills… more
- CSL Behring (King Of Prussia, PA)
- …delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other ... Regulatory CMC. + Proactively fosters and promotes effective relationships across Global Regulatory Strategy. Updates and maintains applicable regulatory … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …CFR, Part 820, Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements. The Global Vice President QARA Compliance is ... internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates...recommendations. + Coordinates and leads audit activities with all global regulatory agencies (eg FDA, Notified Bodies,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are ... conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + Other… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business development ... roles and responsibilities of Quality Assurance. + Practical understanding of global regulatory /quality standards and requirements. + Potential for travel… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Interpret statistical results; collaborate with cross-functional teams (clinical operations, regulatory affairs , medical writing, data management) to translate ... Management and Systems collaborating closely with MCA - Medical Affairs and Clinical Affairs - as well...completed on time, within budget, and in compliance with regulatory guidelines. + Design statistical analysis plans for clinical… more
- Olympus Corporation of the Americas (Westborough, MA)
- …conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + Other ... industry experience post-degree preferably in Clinical Research, Clinical Development or Medical Affairs within the medical device industry. + Minimum of 5… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical and Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable ... and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices...+ Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... an integral role in the day-to-day functioning of the global medical safety organization. In this vital role you...5 years Medical Safety or Risk Management Experience (Medical Device preferred to Pharma). + Extended periods of time… more
- Lundbeck (Deerfield, IL)
- …2 years of experience in Biotech, Medical Device or Pharmaceutical regulatory operations, regulatory affairs , marketing operations, or promotional review ... ordering systems, tracking, and reporting. Additionally, in partnership with Regulatory Affairs , Promotional Review Committees (PRC/MLR), and Marketing,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and governance supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the ... improve Olympus compliance profile. + Monitors plans and applies Global regulatory or Olympus requirements into the...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs … more
