Compliance Specialist

Planet Pharma; Saint Paul (MN); Hybrid; USD 34,440 - 40,983; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Job summary

A leading medical company in Saint Paul, MN is seeking a Compliance Specialist to support product hold orders globally. This role focuses on ensuring patient safety and adherence to regulations while coordinating with diverse teams. The ideal candidate will have a relevant Bachelor's degree and some experience in quality compliance. Competitive pay based on skills, with a salary range of $25.00-$29.75/hr and a hybrid work model is offered.

Qualifications

• Requires a Bachelor's degree with 0-2 years of work experience in Quality or regulated industry.
• Experience with FDA regulatory medical device requirements is desirable.
• Capable of effectively managing multiple demands from a variety of sources.

Responsibilities

• Provide guidance and consultation to OU’s for PHO decisions and strategy.
• Monitor PHO status and deadlines.
• Ensure PHO documents are maintained accurately in compliance.

Skills

Quality/Compliance experience

Good understanding of GDP

Excellent written and verbal communication

Education

Bachelor's Degree in Medical/Biological Science/Engineering

Tools

FDA regulatory requirements knowledge

ISO 13485 knowledge

Job description

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This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$25.00/hr - $29.75/hr

11-month contract, potential for extension or conversion

Pay: $25-29.75/hr (based on experience)

Location: Mounds View MN

On site Monday – Thursday, Friday can work remote/from home

Top 3 things the manager is looking for in candidates experience:

1. Bachelor's Degree Required in Medical/ biological science/ Engineering or related discipline.

2. Quality/Compliance experience and working with Quality Management systems in medical device industry or similar environment.

3. Good understanding of GDP and its implementation is required.

Top 3 Tasks or Responsibilities in scope for this role:

1. Provide guidance / consultation to OU’s for PHO decisions and strategy

2. PHO initiation, revisions, execution, and closure

3. Adhere to Regulations + Standards, Implement Continuous Improvement

In this exciting role as a Compliance Specialist on the Enterprise Product Hold Order (PHO) Team, you will be responsible for supporting the scoping of PHOs globally.

This position involves coordination with a diverse group of people across the company. The individual for this role will need to work independently and as a team player with the ability to use sound judgement and work through ambiguous situations utilizing peers and leadership for assistance as appropriate. The ideal candidate would have experience with Product Hold Orders, in complying with Quality regulations, requirements, and standards.

Our Global Quality Strategy is rooted in the Company Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

Responsibilities may include the following and other duties may be assigned.

• Prioritize patient safety and regulatory compliance by acting swiftly in collaboration with cross functional partners to ensure timely processing of PHOs.
• Monitor PHO status and deadlines.
• Gather and document evidence of PHO activities and disposition completion.
• Ensure PHO documents and records are maintained with accuracy and in compliance with good documentation practices and record retention requirements.
• Support continuous improvement projects to increase effectiveness, efficiency, and compliance.
• Ensure alignment with legal and ethical standards of the organization.
• Enforce antibribery and anticompetition laws.
• Ability to work independently with general supervision on larger, moderately complex activities and assignments.
• Make adjustments or recommend enhancements in systems and processes to solve problems or improve effectiveness of job area.
• Communicate primarily and frequently with internal contacts. Contact others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Requires a Bachelor's degree with 0-2 years of work experience in Quality or regulated industry

Nice to Have

· Capable of effectively managing multiple demands from a variety of sources

· Excellent written and verbal communication abilities

· Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive

· Experience supporting internal and external audits

· Experience supporting continuous improvement projects

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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