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Specialist 3 - Regulatory Affairs

Sunrise Systems Inc

West Chester, PA

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JOB DETAILS
SKILLS
Brochures, Change Control, Clinical Research, Communication Skills, Corporate Compliance, Corporate Policies, 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 Development, Product Lifecycle, Product Support, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, 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
4 days ago
Job title: Sr. RA Specialist
Location: West Chester, PA 19380 (Hybrid)
Duration: 06+ months W2 Contract with possible extension

Notes from Manager:
- Role will be located in PA, will be HYBRID, must be able to come to the local PA office when needed
- Bachelor's degree is required
- Must have 4-6 years of experience in Regulatory Affairs
- Must have prior experience in supporting the Regulatory teams
- Must be able to multi-task
- Must have Regulatory experience
- Must be able to handle Regulatory submissions

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.

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
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

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)
Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com

About the Company

S

Sunrise Systems Inc

Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.

We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.

Our collective business experience spans over two and a half decades and ranges from:

  • Business, management, and technical fields
  • Information technology consulting and software solutions.
  • Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
  • Motivating technology staff and establishing partnerships with Fortune 500 companies

Sunrise Systems has a vast range of competence in:

  • Design, development, and support of cloud-based solutions from simple to highly complexed
  • Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
  • Data processing and data migration
  • Application re-engineering and platform migration
  • Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1990
WEBSITE
http://www.sunrisesys.com/