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- Cambridge, MA
new job!

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
new job!

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....

- Bridgewater, NJ
new job!

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.


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....

- Blue Ash, OH

Company Our client is a world leader in medical device technology and a top provider of surgical implants and medical instruments. PositionLeads development of product marketing plans by preparing objectives, strategies, tactics, profit and loss projections, including short and long-term strategiesManages new product development marketing activities for specific products within the respective Group, including new idea review and recommendations, concept and design development, technique....


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....


Join a leading global organization in their Product/ Metabolism discovery and safety studies team. Requires Scientific expertise in biological or chemical sciences of environmental, plant or mammalian studies. ---Participate as Lead Scientist with expertise in Data Chemistry, analysis testing utilizing Chromatography and other relative methodology. ---Support the use of data sets to optimize study design and overall understanding of the compounds behavior ---Manage studies placed with external


Location: San Diego, CA Employment Type: Permanent Context: Our client ss is seeking a Sr. Project Manager to manage research and drug discovery projects from the research/discovery phase through to early clinical development. Preference will be given to candidates who have experience with small molecule therapeutics. The ideal candidate will be an innovative, highly motivated project manager with a strong scientific background in preclinical drug discovery research and project management. The


Fortune 100 Pharmaceutical Company—Los Angeles Area SizzleCompany provides relocation package if required.Company provides a base salary + substantial bonus and stock options. Position Summary The Global Regulatory Affairs (GRA) division provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all company molecules. This role is product-facing and leads the Global Regulatory Team (GRT) in the Regulatory Affairs....

- 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


This unique opportunity reporting to the Vice President, Clinical Development will have a significant role in developing life transforming therapeutics for patients with rare diseases. Looking for a capable, insightful, practical, experienced and skilled physician leader to help plan, develop, execute and analyze clinical study programs in rare bone diseases. The best candidate can manage appropriate protocol development, endpoint development and effective reporting of results, adequate....

- Waltham, MA

Medical director - new products (depending on experience – may be senior or executive position) Reporting to VP & Head of Medical Affairs NA Staff responsibility Potentially yes Employment type Full time Purpose As a member of the NA medical affairs team this person will provide state of the art medical expertise and medical leadership for New Products Essential Responsibilities Lead the NA medical strategy and provide medical leadership and contribution for New ProductsProvide subject....


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....

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