- University of Pennsylvania (Philadelphia, PA)
- …needed and/or planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA, ... needed and/or planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA,… more
- Teleflex (Maple Grove, MN)
- …make a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies, submissions , and regulatory reviews ... others on compliance matters. * Brings Regulatory Affairs questions/issues to the attention of RA management...is required including marketing reviews. * Regulatory affairs experience in domestic and international submissions ,… more
- J&J Family of Companies (Raritan, NJ)
- …global health authorities' submissions technical documents. * Serves as a Regulatory Affairs subject matter expert on new product development and engineering ... Senior Regulatory Affairs Program Lead (Robotics &...development stages and generating submission ready documentation and authoring regulatory submissions . Additionally, this individual will support… more
- Abbott (Sylmar, CA)
- …CA currently has an on-site opportunity for a **Senior Regulatory Affairs Specialist** with our Cardiac Rhythm Management division. This position leads ... applicable regulations. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment...attention to detail. **Preferred** **Qualifications** + Master's Degree in Regulatory Affairs and may be used in… more
- Teleflex (MA)
- Sr. Regulatory Affairs Manager - Product Management **Date:** Oct 25, 2024 **Location:** Remote, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% ... that make a difference in patients' lives. **Position Summary** The Senior Manager, Regulatory Affairs is an experienced leadership position with a deep… more
- Integra LifeSciences (Braintree, MA)
- …are challenging what's possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is an intermediate level role responsible for ... regulations in the US, EU, Canada and globally. The Regulatory Affairs Specialist is responsible for providing...strategies, and revise technical documentation for existing and new regulatory submissions . + Aid Supervisor in the… more
- Actalent (Bridgewater, NJ)
- …clinical development teams, along with external consultants. The Head of Regulatory Affairs will be a key member of management and product development ... AffairsJob Description We are seeking a Head of Regulatory Affairs to be based in Bridgewater,...the Chief Scientific Officer, this position will lead our regulatory submissions as well as preside over… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls (CMC) works with ... enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications… more
- Teleflex (Morrisville, NC)
- …procedures and communicate to internal stakeholders and leaders. * Propose solutions for Regulatory Affairs questions/issues to RA management . * Review and ... for Class II and III Pre-Submission Meetings and PMA submissions , Health Canada for Class III/IV submissions ,... regulatory , including compliance, design control, and risk management activities. * Strong regulatory affairs… more
- United Therapeutics (Silver Spring, MD)
- …and in writing, with colleagues and management , both within and outside regulatory affairs , including upper management , and external government personnel ... and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior ... advice and oversight to project teams and supporting regulatory submissions and department activities. This role… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Analyst of Regulatory Affairs Label Management is responsible for monitoring ... related life sciences. + Required Experience: 4+ years in regulatory affairs or R&D. + Experience working...oral and written. + Preferred: Experience working with electronic regulatory submissions and data standards and prior… more
- Abbott (Sylmar, CA)
- …arrhythmias, or irregular heartbeats. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist II** to work on-site at our Cardiac ... requests for product release. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment initiatives as identified… more
- Medtronic (North Haven, CT)
- …innovation in a more connected, compassionate world. **A Day in the Life** The Regulatory Affairs Program Manager will lead the strategic planning and execution ... of regulatory submissions and compliance initiatives within the...+ Bachelors degree with 5+ years of medical device regulatory affairs experience OR + An advanced… more
- Boehringer Ingelheim (Ridgefield, CT)
- … strategy expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory ... assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: + Regulatory...all local and global project related documentation such as management summaries, TALC / HPSC / DC pre-reads, are… more
- Medtronic (Lafayette, CO)
- …in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and ... + Provide business and product information to the international regulatory affairs team to enable development and...or performs coordination and preparation of document packages for regulatory submissions from all areas of company,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the Infusion Process Excellence RA ... to business partners, the Assoc Director of Process Excellence Regulatory Affairs , and execute regulatory ...develops regulatory strategies and tactical plans for submissions regulatory bodies + Liaises with global… more
- Randstad US (Chicago, IL)
- …across Company's product portfolio to Health Authorities for global development and lifecycle management submissions . + The Regulatory Operations Manager is ... Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions Equal Opportunity… more
- Fresenius Medical Center (Waltham, MA)
- …activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals and ... A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of...the regulatory document management system, regulatory information system, and electronic submissions . +… more
- Integra LifeSciences (Harrisburg, PA)
- … strategies, and create and revise technical documentation for existing and new regulatory submissions . + Prepares regulatory strategies with minimal ... and response to questions with minimal supervision. + Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12258BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission ... solutions. + Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects...of immediate job area. + Write, review, and file regulatory submissions to ensure MicroVention devices are… more