Sr. Regulatory Affairs Specialist ACS Solutions Work From Home, GA Full Time $35.00 - $40.00/Hour

[Kate]

ACS Solutions has an immediate need for a Sr. Regulatory Affairs Specialist with experience in the Manufacturing Industry . This is a 6 monthly contract opportunity. Our client is a leading Manufacturing company.

Please review the job description below:

Position Purpose:

• Provide technical leadership in the development and implementation of regulatory strategies of glove products to support the achievement of business objectives for client business units, while ensuring compliance with domestic and international regulations. Provide a regulatory perspective and input to other functions on safety and quality issues for a cohesive response to the business units that will ensure corporate compliance with the regulations. Provide regulatory training and strategic regulatory assessments to the research and development teams in support of new technology development within the glove product line that are cognizant of product testing and other requirements for regulatory approval in global markets.

Expectations and Responsibilities:

• . Assist and document domestic product specific regulatory strategies.
• Assist in the preparation of accurate regulatory submissions to secure timely approvals in support of business initiatives.
• Monitor the development of regulatory initiatives and communicate potential business impact to direct manager.
• Provide an interpretation of regulatory requirements, both domestic and international to the appropriate business team members and highlight implications of differences with respect to product development and testing activities to minimize overall development activities while bringing speed to the global registration process.
• Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective action.
• Assist with regulatory inquiries to ensure that registrations and approvals are granted without delay.
• Participate in review of unregulated products to ensure boundary adherence.

The main challenges of the position are:

• Understanding the various domestic and international business needs.
• Understanding and interpreting domestic and international regulations relative to new technology and product development.
• Having the ability to understand the technical aspects of the vast array of regulated products manufactured and/or marketed by the business units.
• Having the ability to understand issues pertaining to use of chemicals of concern as identified by regulatory agencies
• Have the insight to problem-solve proactively on regulatory and associated quality issues.
• Understanding various regulatory options for rapid commercialization of new technologies while keeping the businesses informed of costs, timing and competitive access.
• Comply with policies, internal controls and global regulations.
  
  Qualifications/Education/Experience Required:
• A broad technical background is required; preferably a bachelor’s degree within a major scientific discipline and 3-5 years of relevant technical experience or a graduate level degree with 0-2 years of relevant experience. Relevant experience must include prior medical device experience including authoring or assisting with FDA 510(k) and Health Canada device submissions. Must have knowledge of QSR/GMP regulations. Must possess an Understanding of the product development process and understand the aspects of global product launches. Must have exceptional writing and communication skills. Experience with OTC Monograph drugs, cosmetics and Natural Health Products is a plus. Understanding of Prop 65 requirements is a plus.

The target compensation for this role is between or $35 - $40 per hour. Actual compensation may vary, depending on an individual’s experience, qualifications, and location.

If it creates an interest for you, please email me the latest copy of your resume, through this posting.

Thanks and regards,

BABLU KUMAR​ Associate ‑ Recruitment​

A:​ 2400 Meadowbrook Parkway, Duluth, GA 30096​ P:​ (+1) 678-648-7406​

ABOUT ACS Solutions.

ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.

ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.

ACS solutions has multiple subsidiaries, each focused on the unique area of business:

· Analysts international Corporation (Staff Augmentation Services)

· The Ascent Services Group Inc. (Life Sciences Talent Solutions)

· HireGenics, (Payrolling, IC Compliance, & MSP Services)

· DATA Inc. (Information Technology- staffing)

Recent Awards and Recognitions:

· 6th largest IT staffing firm in the US. (Staffing Industry Analysts (SIA) 2019)

· Largest Minority IT Staffing Firm in the US. (SIA 2019)

· ClearlyRated® 2020 Best of Staffing award winner for providing remarkable service quality to our clients. This is our ninth consecutive win.

IT and Industry certifications:

· Microsoft Gold Partner: Application Development, Cloud Platform, Data Analytics, Data Center, DevOps, Data Platform

· AWS Managed Services Partner

· Google Cloud Partner

· ISO 27001:2013 Certified for Data Security

· ISTQB Gold Partner

· ISMS (ISO 27001:2017)

· SOC2 Type II Compliant

• Support regulatory compliance and submissions
• Filing documents related to regulatory submissions
• Ensure compliance to existing regulatory submissions
• Preparing regulatory documents and/or submissions
• Submit regulatory applications and internal regulatory file documentation
• Verify compliance with regulatory requirements
• Ensure compliance with regulatory requirements
• Assure compliance of regulatory files
• Providing regulatory and compliance guidance
• Prepare submissions and reports for regulatory agencies
• Ensure compliance to regulatory standards
• Support and ensure regulatory compliance
• Discuss regulatory issues and submission requirements
• Formulate or implement regulatory affairs policies and procedures to ensure regulatory compliance
• Assisting regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions
• Maintain regulatory records for regulatory activities and applications
• Prepare regulatory document submissions and timely submit
• Review of regulatory quality documents
• Compile and maintain appropriate technical documents for regulatory submissions
• Assure global regulatory compliance of company products

Recommended Skills​

Administration
Ensure Compliance
Provide Direction
Provide Actionable Feedback
Prepare Regulatory Submission
Provide Regulatory Support