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Regulatory Affairs Specialist Jobs in Pennsylvania

22 jobs

Reference Number: 1973 Location: Western Philadelphia, PA & Durham, NC Dynamic growing international medical device company is seeking to hire two Sr. RA Specialists – the openings are due to recent promotions. Current openings will cover the Regulatory Affairs support of their US, Canadian and European teams. Products are Class II and serve various surgical and medical specialties. Most signif...
Kelly Outsourcing and Consulting Group, a division of Kelly Services, Inc., is seeking multiple?Regulatory Affairs Specialists with medical device experience?for multiple 2+ year project opportunities.? These positions come with enhanced benefits (see below).? Candidates must able to work onsite at one of the following locations - Raynham, MA; West Chester, PA or?Warsaw, IN.? The Regulatory Affair...
Job Description: Temporary to Permanent - Regulatory Affairs Specialists in Philadelphia, PA Regulatory Affairs Specialist responsible for the administration Clinical, Regulatory, and Quality Control systems. Manage all imaging documentation regarding governed compliance on various levels; internal and external customer groups. Respond and handle all complaints and device reporting requirements. ...
Job Description: Senior Regulatory Affairs SpecialistPrepare submissions for New Drug and Abbreviated Drug Product Applications according to ICH-CTD.Prepare annual reports for NDA/ANDAs by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to an application and tracking progress of their preparation.Review of documents and interacting w...
Opportunity: Experienced mid-level leadership position which integrates regulatory knowledge throughout the product lifecycle with aspects of effective project management and strategy. The position supports the Regulatory Affairs function by leading the coordination and preparation of global regulatory premarket submissions with a primary focus on US, EU and Canadian submissions. Division Inform...
Opportunity: Under the guidance of the Sr. Regulatory Affairs Leader: Strategic Manufacturing, support the Strategic Manufacturing group to prepare global submission and registration documents in support of new of existing product offerings. The candidate is required to work effectively with cross-functional groups and global regulatory affairs contacts to maintain worldwide Regulatory clearances...
Assist Regulatory Affairs function, through the following activities: o Interfacing with various departments to collect and organize required documentation materials. o Provide Regulatory Affairs support to Strategic Manufacturing under supervision. o Communicate with internal stakeholders impacted by Strategic Manufacturing Assist in producing new or revised global medical device submissions ...
Kelly Outsourcing and Consulting Group, a division of Kelly Services, Inc., is seeking multiple Regulatory Affairs Specialists with medical device experience for multiple 2+ year project opportunities. These positions come with enhanced benefits (see below). Candidates must able to work onsite at one of the following locations - Raynham, MA; West Chester, PA or Warsaw, IN. The Regulatory Affairs S...
JOB FUNCTION: Scientific JOB TYPE: Temp LOCATION: Wayne, PA COMPENSATION: $40/hr - $45/hr MINIMUM EDUCATION: Bachelor's Degree POSTED: Jul 7, 2016 Our client is a global specialty bio-pharmaceutical company, with a huge line of products and brands. Salary/Hourly Rate: $40-45/hr Position Overview: The successful candidate will have an understanding of current US, EU, Japan and International...
Advanced Bionics is the global leader in the research and development of the most advanced cochlear implant systems in the world. Founded in 1993 and a subsidiary of the Sonova Group since 2009, the company has more than 900 employees worldwide with the distribution of its products in over 50 countries in the world. AB develops cutting-edge cochlear implant technology that allows recipients to hea...
••Lead product family focused team of Regulatory Associate(s) and or Specialist(s) utilizing strong technical regulatory skills in developing strategies for complex projects and issue. •Mentor Regulatory Affairs Associates and Specialists •Participate on multidisciplinary teams and communicate regulatory requirements effectively. •Provide regulatory input to product lifecycle planning. •Conduc...
This role advises the creative, application and commercial departments on the safe use and Regulatory Compliance of formulas. This includes the execution of regulatory compliance reviews, preparation of various documents supporting the regulatory compliance of these formulas, frequent direct interaction with major customers (both internal and external) and direct interaction with regulatory author...
The International Regulatory Affairs Specialist writes, submits and gains approval of product registrations and other submissions to international Regulatory agencies. This position entails development of submissions in conjunction with other Globus departments, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusia...
The Regulatory Affairs Specialist assists in writing, submitting and gaining clearance for 510(k) submissions and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual...
The International Regulatory Affairs Specialist writes, submits and gains approval of product registrations and other submissions to international Regulatory agencies. This position entails development of submissions in conjunction with other Globus departments, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusia...
The International Regulatory Affairs Specialist writes, submits and gains approval of product registrations and other submissions to international Regulatory agencies. This position entails development of submissions in conjunction with other Globus departments, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusia...
The International Regulatory Affairs Specialist writes, submits and gains approval of product registrations and other submissions to international Regulatory agencies. This position entails development of submissions in conjunction with other Globus departments, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusia...
The Regulatory Affairs Specialist assists in writing, submitting and gaining clearance for 510(k) submissions and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual...
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. Integra's orthopedic products include devices and implants for spine, foot and ankle, hand...
The Regulatory Affairs Specialist assists in writing, submitting and gaining clearance for 510(k) submissions and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual...