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Job #03347

About our client Our client is a publicly traded life sciences company that is recognized as a leader in the parenteral packaging technology and components sector. The organization is highly profitable and boasts both an experienced management team and a global customer base. They have also developed an industry-wide reputation for their commitment to quality and innovation. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Regulatory Affairs Specialist Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare, coordinate, review and submit regulatory documents 2) Work on submissions as well as compliance issues related to DMFs, 510(k)s and customer requests 3) Provide regulatory guidance on medical devices and medical device components 4) Participate in various individual and team projects 5) Work on regulatory projects, training and programs 6) Prepare and participate in training activities related to the regulatory aspects of the company 7) Assist in providing regulatory support in the form of suggestions, options and feedback to various departments, projects, teams, customers, etc. 8) Oversee regulatory administration, support and maintenance 9) Monitor, provide and solicit inputs from others on necessary information for revisions, additions or new DMFs, 510(k)s and other regulatory documents 10) Assist with submissions to ensure that they are accurate, complete, compliant and submitted to the applicable regulatory agency within appropriate due dates, defined timeframes, project deadlines, etc. 11) Respond and assist with customer inquiries 12) Provide guidance in developing standardized forms to use for various inquiries 13) Assist in resolving issues arising from customer requests 14) Participate and represent regulatory on project teams 15) Communicate team/project progress/status, decisions, timelines, etc. 16) Plan, develop and coordinate submissions to regulatory agencies (as needed) 17) Provide feedback to teams on regulatory aspects related to their projects 18) Review and approve departmental procedures 19) Perform any other additional business specific tasks as communicated (when needed) 20) Review and provide comments on site operating instructions, other procedures, training documents/programs, publications, brochures, etc. 21) Perform any other additional departmental specific tasks as communicated (when needed) 22) Communicate and work with external clients and internal customers or teams to accomplish business requirements and objectives 23) Provide regulatory guidance for issues to internal departments 24) Support departmental and company objectives 25) Continue educational efforts via training and other forums to enhance extant knowledge base as well as keep current of regulatory climate, issues and compliance Requirements 1) BS in a scientific discipline 2) Minimum 5 years of experience in the medical device, pharmaceutical or associated industry 3) Previous experience and knowledge of FDA guidances for drugs, biologics and/or medical devices, ICH guidelines, pharmaceutical and medical device cGMPs, (21 CFR 820, 210 & 2 11), ISO standards (ISO 1348 5) and regulatory filings 4) Experience in interacting with regulatory authorities a plus 5) Good understanding of regulations 6) Excellent interpersonal and communication (verbal and written) skills 7) Ability to work independently and in a team environment 8) Ability to plan and organize as well as the flexibility to adjust to a rapid changing environment 9) Willingness to travel up to 25% (may vary)