Compliance Manager

Phase2 Technology; Shirley (NY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Phase2 Technology in Shirley, NY is seeking a Compliance Coordinator to support medical device regulatory programs and ensure adherence to applicable standards across the company.

You will review products, assist audits, maintain documentation, and coordinate with Quality and Engineering. Travel between Shirley and Florham Park may be required.

The role requires an Associate's degree and 2–3 years in medical device compliance, plus strong writing and computer skills.

Qualifications

• Associate's degree required with 2–3 years in medical device regulatory compliance.
• Confident, professional, and self-motivated with interest in regulatory requirements.
• Strong computer and writing skills; ability to work independently and in a team.

Responsibilities

• Identifies compliance requirements and coordinates with other departments.
• Supports regulatory adherence during audits and maintains documentation.
• Reviews new products/processes for compliance and updates files.
• Assists in preparing systems, procedures, and policies for compliance.

Skills

Regulatory knowledge

Documentation

Written communication

Teamwork

Self-motivation

Education

Associate's degree

Tools

Microsoft Office

Spreadsheets

Job description

REMOTE WORK OPTIONS ARE AVAILABLE

ESSENTIAL JOB FUNCTIONS

1. Identifies functions and business practices requiring compliance activities and assists in coordinating with other organizational functions / departments on the elements of the compliance program to ensure that the whole staff is knowledgeable of and comply with applicable federal, country and industry standards.
2. Complies with federal, country and regulatory agencies by studying existing and new requirements; enforcing adherence to requirements; advising management on needed actions.
3. Provides administrative support by implementing systems, procedures, and policies; completing projects in support of compliance team.
4. Answers questions both internally and externally and responds to all compliance requests and spreadsheets.
5. Reviews all new products, systems or processes to ensure compliance.
6. Identifying and assessing areas of significant business risk and works with Quality and Engineering to mitigate these risks.
7. Define, develop and maintain the compliance documentation structure and files. Work with Marketing Communication to maintain accurate compliance documentation is posted on the company website.
8. Provide assistance and support with regulatory elements for the technical file and tollgates.
9. Supports and provides regulatory adherence during internal / external audits
10. Increases compliance knowledge by participating in educational opportunities; reading publications, training sessions, webinars.
11. All other duties as assigned

Travel: As needed travel between the Shirley, NY & Florham Park, NJ sites.

QUALIFICATIONS/SPECIAL SKILLS

The compliance coordinator is required to have an Associate's degree and 2 -3 years' experience in the medical device compliance field dealing with regulatory requirements. Should be confident, professional and self-motivated with a keen interest in ethical, legal and regulatory requirements. Requires both computer and writing skills, with the ability to work on their own initiative and as part of a team.