Regulatory Affairs Specialist- US Markets

Medline Industries, LP; Illinois; On-site; USD 79,000 - 116,000; Full time

Job summary

Medline Industries, LP is seeking a Regulatory Affairs Specialist for US Markets to oversee regulatory activities for device approvals. This role involves crafting comprehensive regulatory strategies, ensuring compliance with regulatory standards, and collaborating with internal teams. The ideal candidate will have a relevant degree and experience in regulatory affairs, providing a critical resource within a dynamic team.

Benefits

Health insurance

401(k) contributions

Paid time off

Qualifications

• 2 years of experience in medical device regulatory affairs.
• Understanding of FDA regulations and guidelines.
• Experience with regulatory submissions and filings.

Responsibilities

• Plan and execute regulatory activities for approvals.
• Communicate regulatory requirements to stakeholders.
• Participate in product labeling and claims development.

Skills

Understanding of current Regulatory environment

Applied knowledge of FDA regulations

Ability to evaluate compliance

Education

B.A. or B.S. in life sciences or related field

Job description

Regulatory Affairs Specialist- US Markets

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Regulatory Affairs Specialist- US Markets

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Job Summary

Under general supervision, the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete short-term department goals.

Job Summary

Under general supervision, the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete short-term department goals.

Job Description

• In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s).
• Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways and strategies.
• Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met.
• Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical in-formation, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators.
• Participate in the development, review, and substantiation of product labeling and claims.
• Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert.
  
  

Minimum Job Requirements

Education

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
  
  

Work Experience

• 2 years of experience in medical device regulatory affairs or quality assurance.
  
  

Knowledge / Skills / Abilities

• Understanding of the current Regulatory environment and demonstrating the ability to perform within.
• Applied knowledge of FDA regulations and guidelines.
• Ability to evaluate information to determine compliance with standards, laws, and regulations.
• Travel required up to 5%.
  
  

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The Anticipated Salary Range For This Position

$79,560.00 - $115,440.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Medical Equipment Manufacturing

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