Compliance Specialist 2

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Compliance Specialist 2.

Job Description:

Job Title: Compliance Specialist 2

Job Type: Contract

Job Location: Sunnyvale, CA

Work Schedule: Onsite

Pay Rate: $48 on W2

Description:

Primary Function of Position

• The primary function of this position is to coordinate and assist field action team related activities. They are to possess a general understanding of the field action process.
• They will work closely with field action team to ensure that appropriate processing of customer acknowledgement forms and inquiries related to field actions.
• Collaboration with business partners, field action team, and management to address customer escalation concerns as it related to field action. They will have strong organization and communications skills to support established customer-focused quality initiatives.
• The specialist will also be expected to assist the team in record retention based on company and regulatory standards.

Essential Job Duties

• Processing and reconciling customer returned acknowledgement forms per
  regulations and internal procedures.
• Provides guidance to customers for product recall related questions.
• Help provide updates on effectiveness levels for each field action.
• Assist in preparing monthly regulatory reports on field action effectiveness status.
• Manage the recalls inbox and complete requests as needed.
• Assist in providing status updates to cross-functional teams when needed.
• Assists with providing information to Audit Management on maintaining audit
  readiness for internal and external audits.
• Performs assessments, develops action plans, and drives plan to effectively
  manage recall inbox and address any urgent communication appropriately.
• Collaborate in development, maintenance, and improve processes and
  procedures for various processes within the quality management system and
  where necessary.

Preferred Skills and Experience

• Minimum Bachelor Degree – BS degree in Engineering, Physical or Biological
  Science, or other technical field
• Minimum 4 plus years’ experience in product quality or regulatory compliance (or
  combined experience) in the medical device or other regulated industry.
• Has general understanding of applicable US medical device regulations (e.g., 21
  CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO
  14971), and international regulations (e.g., CMDR – Canada, European, RDC –
  Brazil)
• Experience with computer regulations/standards and methodologies
• Strong organizational, written, and verbal communication skills; plus critical
  thinking skills and proficient in constructive dialogue
• Effective at prioritizing tasks and responsibilities within a fast-paced, dynamic
  environment
• Effective in collaborating and partnering with field action team and displaying an
  appropriate level of assertiveness
• Experience working directly with the FDA, Notified Body, or other governmental
  agencies (preferred)

About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.

Interested in Applying?

Please apply with your most current resume. Feel free to contact Gaurav Bhatia for more details.

Maxonic, Inc. is a certified minority-owned technology consulting and staffing firm founded in 2002. We provide technology consulting and staffing services to Fortune 500 companies across the country. We collaborate with clients to design, develop and implement business-driven technology solutions. We have deep domain expertise with multiple big data platforms and have strong partnerships with industry leaders in the space. The founders have over 40 years of experience helping clients and consultants succeed. Our commitment is to provide customers with an honest, personalized, face-to-face, long-term relationship and provide consultants with ethical, respectful, and stress-free care. We believe in the power of building successful careers for everyone.

Specialties:
Staff Augmentation
Professional Services - Artificial Intelligence, Big Data Analytics, Mobile Solutions, and Cloud Solutions
Outsourced Services, Administration and Support
Contingent Workforce Services