Compliance Specialist/Regulatory Affairs (Medical Devices)

Job Description

Job 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)

Della Infotech Inc is in the staffing business for 10 years. Over the years, we have placed hundreds of candidates to various temp and permanent positions with our 50+ happy clients all over US and Canada including Fortune 500 corporations.

Company Description

Della Infotech Inc is in the staffing business for 10 years. Over the years, we have placed hundreds of candidates to various temp and permanent positions with our 50+ happy clients all over US and Canada including Fortune 500 corporations.