Regulatory Affairs Specialist

RiseMe; Illinois; Hybrid; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a Regulatory Specialist to lead global regulatory activities for medical devices. Under supervision, you will plan strategies for new devices, launch markets, and post-market changes, ensuring compliance and quality of supporting information.

Collaborate with cross-functional teams to prepare submissions, review documentation, and support regulatory responses. Travel up to 5% to coordinate with global/regulatory partners.

Qualifications

• Two years of experience in medical device regulatory affairs or quality assurance.
• Knowledge of current regulatory environment and FDA regulations/guidelines.
• Ability to evaluate information to determine regulatory compliance.

Responsibilities

• Determine requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned markets.
• Communicate regulatory requirements to internal or external customers and recommend pathways.
• Review and provide feedback on documentation to ensure regulatory requirements are met.
• Complete/regulatory filings by coordinating with internal/external groups and addressing questions from regulators.
• Contribute to development and substantiation of product labeling and claims.
• Present objectives with team members and provide regulatory expertise.

Skills

FDA regulations

Regulatory strategy

Regulatory affairs

Education

Bachelor’s degree in life sciences

Job description

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 information, 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:

$79,000.00 - $119,000.00 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

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.