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Regulatory Affairs

Pyramid, Inc

West Chester, PA

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JOB DETAILS
SALARY
$50–$57 Per Hour
JOB TYPE
Full-time
SKILLS
Brochures, Change Control, Clinical Research, Communication Skills, Corporate Compliance, Corporate Policies, Database Administration, Detail Oriented, Disease, Employee Benefits, Engineering Change Order, FDA Requirements, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Green Business, GxP, Healthcare, Identify Issues, Medical Equipment, Monitor Regulations, Multitasking, Operations Research, Organizational Skills, Orthopedics, People Management, Presentation/Verbal Skills, Problem Solving Skills, Procedure Implementation, Product Development, Product Lifecycle, Product Management, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Request for Information (RFI), Risk Analysis, Safety/Work Safety, Staff Training, Standards Organizations, Strategic Planning, Training/Teaching, Writing Skills
LOCATION
West Chester, PA
POSTED
12 days ago
Immediate need for a talented Regulatory Affairs. This is a 06 Months Contract opportunity with long-term potential and is located in West Chester, PA (Hybrid). Please review the job description below and contact me ASAP if you are interested.Job ID:26-18825Pay Range: $50 - $57/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Compile, prepare, review and submit regulatory submission to regulatory authorities Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division orthopedic devices Interface with Product Development to obtain necessary information for regulatory submissions Review/approve Custom Device Requests Review/approve Engineering Change Requests/Notices Prepare export certificates, medical device listings, and annual establishment registrations Respond to requests for information on import detentions Maintain regulatory database - ongoing update of database with regulatory information Assist in the development and implementation of SOPs and systems to track and manage product-associated events Assist in the development of regulatory strategy and update strategy based upon regulatory changes Provide regulatory input to product lifecycle planning Evaluate regulatory impact on proposed products Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval Determine and communicate submission and approval requirements Begin to participate in risk-benefit analysis for regulatory compliance Submit and review change controls to determine the level of change and consequent submission requirements Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Provide training for staff on current and new regulatory requirements Communicate regulatory agency/industry positions within the regulatory department Problem-solve with and advise internal stakeholders on regulatory issues Identify standards for the organization’s products Participate in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. Review/approve labeling: device labels, brochures, technique guides, bulletins, updates, etc. Responsible for communicating business related issues or opportunities to next management level Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as neededKey Requirements and Technology Experience: Skills -Regulatory Submission, FDA 510(k) submissions, labeling reviews, change control assessment, global regulatory registrations BS Degree in Science or Engineering required Four to six years related regulatory experience in medical devices or relevant medical device industry experience Excellent written and oral communication skills Excellent organizational skills preferred Ability to handle multiple tasks and be detail oriented Ability to apply risk-benefit analysis techniques General knowledge of Submission types and requirements Knowledge of clinical research, clinical operations, and nonclinical, quality, and regulatory requirements and GxPs (GCPs, GLPs, GMPs)Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.#Mor2

About the Company

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Pyramid, Inc