Specialist 3 - Regulatory Affairs

The Fountain Group LLC

West Chester, PA

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JOB DETAILS

SALARY

$52–$55 Per Hour

SKILLS

Brochures, Clinical Research, Communication Skills, Database Administration, Detail Oriented, Disease, Engineering Change Order, FDA (Food and Drug Administration), Federal Laws and Regulations, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), GxP, Medical Equipment, Multitasking, Operations Research, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Procedure Implementation, Product Lifecycle, Product Support, Regulations, Regulatory Compliance, Regulatory Requirements, Request for Information (RFI), Risk Analysis, Staff Training, Standards Organizations, State Laws and Regulations, Strategic Planning, Support Documentation, Training/Teaching, Writing Skills

LOCATION

West Chester, PA

POSTED

19 days ago

The Fountain Group is currently seeking a Regulatory Affairs III for a prominent client of ours. This position is located at West Chester, PA. Details for the position are as follows:

Title: Regulatory Affairs III
Location: West Chester, PA
Duration: 6 months(With Possible Extension/Hire)
Pay : $52-$55/ hours

Job Description:
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.

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.

Experience & Education:

BS Degree in Science or Engineering required
Four to six years related regulatory experience in medical devices or relevant medical device industry experience

Required Skills:

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)

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About the Company

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE

500 to 999 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

https://www.thefountaingroup.com/