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About our client
Our client is a leading medical device company headquartered in Pennsylvania, which is focused on the development and commercialization of various fluid collection devices. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term development of its employees.
Position	Location
Regulatory Affairs Manager	Pennsylvania
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Manage and organize the Regulatory Affairs Department 2) Ensure that departmental objectives are implemented in line with the overall quality/corporate goals 3) Ensure compliance with the US FDA Code of Federal Regulations, EUIVDD, EN 13485 and other quality standards (as appropriate) 4) Handle design input, review, out-put and verification, validation, transfer as well as change control 5) Provide updates (as needed) to the supervisor regarding regulatory status and requirements (both US and European) of company products 6) Implement CE Marking to products as per IVDD 98/79/EEC 7) Compile device master records, technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports 8) Ensure timely submissions to CBER and TUV etc., to meet company product(s) and regulatory requirements 9) Provide related training and support to departments (as needed) 10) Ensure product compliance with all approved licenses 11) Review change control and deviation requests 12) Ensure that the staff understands and complies with the requirements of cGMP (as applied to the company’s products) 13) Compile biologic product deviation reports in compliance with the Code of Federal Regulations 14) Review quality system reports for adequacy and compliance with company and regulatory requirements 15) Participate in investigating failures and continuous improvement initiatives 16) Write and maintain procedures relating to the Regulatory Affairs function, preparation and presentation of quality reports, data as well as KPIs for management reviews 17) Provide regulatory support (as required) in the evaluation of customer complaints 18) Ensure that complaint reports are closed out as per approved procedure 19) Participate in the development, management and maintenance of the company’s quality system to meet the requirements of US FDA (21CFR 820 QSR), ISO9001, ISO 13485 and all applicable quality standards 20) Liaise with Quality Department and QA/QC to ensure post-market surveillance/vigilance systems 21) Update the RA/QA Director of any SAEs 22) Assist other members of the RA/QA Department 23) Maintain current knowledge of related trends, regulations, etc. 24) Comply with and maintain the company’s quality systems 25) Complete other tasks as assigned by the Senior Vice President and RA/QA
Requirements
1) Bachelor’s degree in Quality or Science (Chemistry, Biology or Medical Technology) 2) 5 years of experience in a drug manufacturing, medical device, pharmaceutical or biologics industry in a RA/QA position 3) Minimum 2 years of supervisory experience preferred 4) Qualified Auditor preferred with EU Six Sigma experience 5) Experience in developing, managing regulatory submissions and documentation (BPDR, MDR, facility registrations, IND and 510k) 6) Experience in cGMPs, FDA regulations and SOP development 7) Expertise in internal and external audit processes 8) Demonstrated success with working in a team environment 9) Proficiency in computers and a working knowledge of basic computer software (MS Office preferred) 10) Understanding of QA audit functions and QC principles 11) Excellent communication skills (verbal and written), including the ability to conduct verbal presentations 12) Ability to lift or pull up to 50 pounds and operate a computer keyboard/calculator 13) Ability to view video display terminal images and sit for extended periods of time (up to 4 hours at a time) 14) Occupational exposure to blood borne pathogens 15) Willingness to travel by car and/or airplane – up to 25% or more (as required)