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Regulatory Affairs Specialist 3

Integrated Resources, Inc

West Chester, PA

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JOB DETAILS
SKILLS
Brochures, Communication Skills, Corporate Compliance, Corporate Policies, Database Administration, Disease, Engineering Change Order, FDA (Food and Drug Administration), Federal Laws and Regulations, Medical Equipment, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Procedure Implementation, Product Lifecycle, Product Support, Regulations, Regulatory Compliance, Request for Information (RFI), Risk Analysis, Standards Organizations, State Laws and Regulations, Strategic Planning, Support Documentation, Writing Skills
LOCATION
West Chester, PA
POSTED
Today
Position Job Title: Sr. RA Specialist

SECTION 1: JOB SUMMARY*
Prepare regulatory documentation to support the market distribution of new and modified
medical devices (510(k)/NTF) in US, Canada, and EU. Support global registrations in rest of
world. Review device labeling, including all graphic material. Prepare export certificates, medical device listings, annual establishment registrations for submission to the U.S. Food and Drug Administration (FDA). Assist group in maintaining regulatory databases for all products. Provide support to Regulatory Manager for special projects as needed.

SECTION 2: DUTIES & RESPONSIBILITIES*
In accordance with all applicable federal, state and local laws/regulations and Corporate
Pharmaceutical, procedures and guidelines, this position:

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 needed

SECTION 3: EXPERIENCE AND EDUCATION*
BS Degree in Science or Engineering required
Four to six years related regulatory experience in medical devices or relevant medical device industry experience

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and
AFFILIATIONS*
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)

About the Company

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Integrated Resources, Inc