Regulatory Affairs Manager
Our client, a medical device company in Bethlehem, PA, is looking for a Regulatory Affairs Manager. The main functions of this role will consist of regulatory functions related to ensuring compliance to applicable US FDA, ISO EU, Canadian, and other International Ministry of Health requirements applied to currently approved products and products under development. Additionally, responsibilities include interacting with the FDA and other domestic and international regulatory agencies on matters related to establishment registrations, site licensing, product marketing applications, facility inspections, etc.
On a day-to-day basis, this person will be responsible for:
- The preparation and maintenance of in vitro diagnostic and medical device product marketing applications.
- Completing and submitting necessary pre-market applications (510(k), IDE, PMA, Laser Product Annual Reports) for products to the FDA.
- Facilitating and overseeing the daily operations of regulatory affairs processes to ensure compliance with routine regulatory reporting obligations (e.g., PMA Annual Reports, Laser Product Annual Reports, license renewals, etc.).
- Developing and maintaining technical files/design dossiers in accordance with the Medical Device Directive and applicable harmonized standards, In Vitro Diagnostic Directive and applicable harmonized standards and other directives/standards as required. Compile device master records, technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to CBER and DGM etc., to meet Company products and regulatory requirements, and compliance to all approved licenses.
- Application and maintenance of Canadian establishment and medical device licenses.
- MDR/Vigilance reporting to FDA, to international agencies including Canadian Health Products and Food Branch Inspectorate, EU Competent Authorities, etc. and to Notified Body as required. Responsibility for MDV assessments of adverse event reports to determine if reportable.
Qualified Candidates will possess a minimum of 5 years experience in regulatory affairs preferably in medical device, though some pharmaceutical experience is acceptable. Candidates must have 510(k) submissions experience and should have in-depth knowledge of ISO standards and systems. Bachelor's degree is required.
Required Skills for Regulatory Affairs Manager Job:
- MEDICAL DEVICE
- REGULATORY AFFAIRS
- FDA
- CANADIAN AND EUROPEAN REGULATIONS
Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
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