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- Aurora, IL
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Responsible for meeting customer requirements associated with the production of Medical Devices beginning with receipt of an order, specifying raw material, and processing to the shipment and documentation of finished goods. Supports the development of internal systems and procedures to meet all customer specific, ISO 13485, and FDA 820/GMP requirements. Responsible for all monitoring and measurement devices. ESSENTIAL FUNCTIONS: · Builds, manages, and sustains a team of technical quality....


Overview: The Surgical Regulatory Affairs Sr Manager handles all regulatory development aspects of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities. Responsibilities: Responsibilities may include but....

- Los Angeles, CA
new job!

Los Angeles, CA Currently looking for an experienced Manager, Regulatory Affairs - CMC to fill an opening with a Fortune 100 Pharmaceutical Company located in Los Angeles, CA. Interested candidates should hold a Bachelor’s Degree (Regulatory Affairs, Life Sciences, or Engineering) and have 6+ years’ regulatory and/or compliance experience. Responsibilities of the Manager, Regulatory Affairs - CMC Responsible for generation of the region-specific regulatory documents Clinical Trial....

- Cambridge, MA

Regulatory Affairs Advisor - Medical Device Cambridge, MA Overview: Our client is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. They are committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. They are currently seeking a Regulatory Affairs Advisor for....

- New Brunswick, NJ

Our client is a leading global manufacturer of specialty chemicals used in a wide variety of consumer and industrial applications. We are conducting a search for a Regulatory Manager for their expending business headquartered in the New Brunswick, NJ area. Reporting to the Vice President of R&D this individual will be responsible for managing the PSRA group plus developing and implementing their regulatory compliance strategy for their worldwide operations. This will include:Implementing....


The position is responsible for planning and preparing complex medical device regulatory submission documents for US, Canada, and EU regulatory filings. Provides support for other global regulatory filings. Utilizing detailed, in-depth understanding of medical device regulation leads anticipates in goal regulatory teams, interprets regulations, and provides regulatory guidance. Support management with regulatory programs planning and implementations of departmental strategies and policies.


Strategic opportunity as North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety (registration); and Regulatory Compliance (EPA). Participate on the Global Leadership Team while developing a challenged, problem-solving analytical team responsible for performing/ delivering scientific studies to ensure a sustainable product safety and registration success. The successful candidate will have a strong background in Scientific....

- Lancaster, SC

We are looking for a Corporate Trainer who will develop, maintain, and administer training programs. General Responsibilities:Work with management to develop and/or implement company training programs and workshop to employees and manager such as training profiles, On the Job Training, Train the Trainer programs, supervisory, management, work skills, and communication.Monitors the effectiveness of training on employees using individual and/or group performance results. Collects feedback on....


This position entails development of submissions in conjunction with other BDI Surgery departments, requiring working knowledge of products under review and of relevant regulations and guidance documents. Also, this position is responsible for writing, supporting, and assisting in gaining approval of product registrations and other submissions to International Business Centers. Qualifications: Bachelors's degree required (healthcare industry) 5-7 years of international regulatory experience....


Looking for candidates with regulatory affairs experience supporting R&D IVD, leading RA projects for new product developments Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This position interfaces with multiple projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional

- Branchburg, NJ

Responsibilities: Reporting to the VP of R&D, this position will oversee all operations to comply with the FDA, USDA, customer and company quality and food safety system standards. Specific responsibilities include:?Design and implement food safety systemsMaintain and monitor all quality and food safety systems (GMP, Allergen Policy, Pest Control, Maintenance Plan etc.)Train all employees in food safety principlesAchieve SQF Level III CertificationEnsure that all raw materials and finished


TITLE: Med Tech Blood Bank Network Administrator LOCATION: Indianapolis, IN Are you considering a career change? Would you be interested in living in a large city that doesn't feel like it. The Indianapolis area has something for everyone. If so, an opportunity to work an established organization that serves several locations in Indiana is looking for someone to join their team. Summary The Blood Bank Network Administrator assists in development of data-driven pre-analytical, analytical, and....

- King of Prussia, PA

The Senior Product Safety Specialist, working closely with each Business Unit for which the position is responsible, will complete activities to assure compliance with legal and corporate product safety and regulatory affairs requirements in a cost effective and efficient manner. The Senior Product Safety Specialist will support the Manager, Product Safety and Regulatory Affairs for each BU for which the position is responsible to implement practical technical and strategic product safety....


The Senior Manager Clinical Operations is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Senior Manager Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of


Three Medical Directors needed The Medical Director is a board-certified physician who has a history of clinical practice, and has significant experience in the cardio therapeutic area, Endocrinology or Renal, Nephrology therapeutic areas. The Medical Director is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience in clinical trials. An ideal candidate should have significant experience in renal cardio disease management and would thrive on proactively....

- Waltham, MA

TOP TIER PHARMACEUTICAL COMPANY in MASSACHUSETTSglobal biopharmaceutical company developing innovative medicines The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates Position SummaryWe have the need for a highly collaborative, experienced Manager of Medical Writing Operations to join our team based in MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure....


High Profile Pharmaceutical company with recent FDA one of a kind approval is hiring a Senior Manager of Regulatory Affairs CMC Reporting to the director technical writing of RA CMC of Regulatory Affairs, the Senior Manager of Regulatory Affairs, CMC will be responsible for the preparation of high quality regulatory submission content focusing on CMC to support global clinical development, registration, and product life cycle management in accordance to regulatory requirements and guidelines.....


Leading Global Pharmaceutical company with office in Waltham Massachusetts Manager, Health Economics & Outcomes Research (HEOR) Position Summary: The Manager for Health Economics & Outcomes Research (HEOR), will be responsible for supporting HEOR activities for company's products. This individual will contribute to evidence generation, development of strategy, data analysis and dissemination and support the HEOR Senior team members (Directors, Senior Directors).....


Director of Clinical Development Cardio This global Pharmaceutical company is the worldwide biologics research and development leader. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Director, Clinical Development in Gaithersburg MD or Cambridge UK, you’ll play a pivotal role in....


PHARMACEUTICAL COMPANY: focused on cns and GI and anti-infective The growth of this Corporation has created a unique opportunity for a variety of positions in Northern New Jersey, accommodating staff in Clinical Operations, Data Management, Biostatistics, Clinical SAS Programming and Regulatory. The Clinical Trials Manager will be able to organize and facilitate the overall planning, coordination and general performance of clinical trials that support the Clinical Development Plan for Clinical

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