Senior Regulatory Affairs Specialist

Job SummaryMedtronic is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for planning and executing regulatory strategy for molding and capital tooling projects, assessing the regulatory impact of post-marketing changes, and leading project teams...

Overview of the Role:The Senior Regulatory Specialist provides comprehensive regulatory expertise, supporting daily departmental operations and collaborating with the Manager of Regulatory Affairs to manage global medical device registrations. This role involves ensuring the department’s compliance with regulatory policies and managing both electronic and...

Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...

We are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This On-site role reports directly to the CEO. The Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory...

Title: Senior Director of Regulatory Affairs Ad/PromoSummary: A global biopharmaceutical company, dedicated to pursing novel therapeutics to aid those with chronic illnesses is looking to grow their Regulatory Affairs team and bring on a Senior Director of Regulatory Affairs Ad/Promo to join their team! The team is growing rapidly as they have had great...

Role: Senior Regulatory Affairs Lead, Location: Orlando, FLAdvise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending country guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives and project strategy.Create detailed written regulatory plans that can be...

Empower. Unite. Care.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud of what you do every day.About NYC Health + HospitalsMetroPlusHealth provides the highest...

Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

Top 3-5 skills, experience or education required1. Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.3. Detail-oriented with the ability to proofread and check documents for accuracy and consistency.Purpose Statement:The Regulatory Affairs Specialist supports the development...

Regulatory Affairs CoordinatorCity: FriscoState: TexasZip: 75034CornerStone Professional Placement has partnered with a reputable medical device manufacturing client seeking a Regulatory Affairs Coordinator. As the Regulatory Affairs Coordinator, you will be responsible for assisting the Regulatory Affairs team with gathering and organizing documents for...

Regulatory Affairs Specialist II Location: Irvine, CA (Hybrid 3 days on site)12 month AssignmentPay Rate: $45-$49/hr.On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE...

Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD). Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the...

JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned...

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and...

Quality and Regulatory Affairs LeaderRapiscan Systems is a leading provider of detection technology, offering cargo and vehicle inspection systems and services for various industries. We strive to deliver best-in-class imaging, high reliability, and operator satisfaction to our customers.The Vice President of Quality and Regulatory Affairs will play a...

Job Title: Director Regulatory AffairsLocation: Weston, FL (near Miami and Fort Lauderdale, Florida (FL))Function: Regulatory AffairsReports to: Chief Regulatory Affairs Officer Job Summary:The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre-...

Yoh is seeking a Regulatory Affairs Specialist for our Pharmaceutical client here in St. Louis, Missouri. Join a growing team! Position Type: Contract (Hybrid) Rate: $30-$34/hr Hours: 8:00 am - 5:00 pm Position Summary:Plan/author/compile drug product dossiers in CTD format for expansion to international marketsPlan/author/compile/submit/manage variations...

Responsibilities: • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending country guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives and project strategy.• Create detailed written regulatory plans that can be used to target domestic and...

Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...