Manager Regulatory Affairs

Medline Industries, LP; Eagan (MN); Hybrid; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Eagan, MI is seeking a Manager Regulatory Affairs to oversee regulatory programs for medical device divisions in a hybrid work model.

This role includes guiding regulatory decisions, leading filings, and coordinating with regulators to ensure compliance across pre- and post-market activities. Bachelor’s degree and 4+ years in regulatory affairs are required. Travel up to 15% may be required.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences or Engineering.
• At least 4 years of regulatory affairs experience for medical devices.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Guide regulatory and licensing decisions based on medical device requirements.
• Lead regulatory filings by coordinating internal and external teams.
• Communicate regulatory requirements to stakeholders.
• Engage with regulators to address non-conformances and questions.
• Develop processes to maintain pre- and post-market regulatory compliance.
• Monitor changes in regulatory environments and advise accordingly.
• Assess records against multiple regulatory sources and standards.

Education

Bachelor’s Degree in Regulatory Affairs/Life Sciences/Engineering

Multi-project management

Regulatory affairs (medical devices)

Tools

Microsoft Word

Microsoft Excel

Job description

Job Summary

Medline Industries has an immediate opening for a Manager Regulatory Affairs at our Eagan, MI location. This role will work a hybrid work model. Oversee regulatory affairs for Medline product divisions.

Major Responsibilities

• Guide regulatory and licensing decision-making processes based on relevant regulatory requirements of medical devices.
• Complete and maintain regulatory filings by leading internal groups, collaborating with external groups, providing direction to obtain supporting technical information, and implementing focused solutions for identified changes and challenges.
• Oversee the communication of regulatory requirements to internal or external customers.
• Lead communication with critical regulators to respond to non-conformances, deficiencies, and questions.
• Develop and implement processes and procedures to maintain regulatory compliance related to medical device pre and post market activities involving regulatory, R&D, quality and medical affairs.
• Monitor changes in the regulatory and legislative environment.
• Recommend regulatory pathways, strategies, solutions, and future actions for specific and diverse scenarios, accounting for business objectives and factors relevant to other departments/functional areas Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements.
• Assess records against multiple requirements sources, including regulations, guidance documents, and standards utilized in various applicable markets that have been identified as applicable.

Management Responsibilities

• --Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments --Day-to-day operations of a group of employees. --May have limited budgetary responsibility and usually contributes to budgetary impact; --Interpret and execute policies for departments/projects and develops. --Recommend and implement new policies or modifications to existing policies. --Provide general guidelines and parameters for staff functioning. --Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Minimum Job Requirements

• Education: Bachelor’s Degree in Regulatory Affairs, Life Sciences (e.g. biology, chemistry) or Engineering. Certification / Licensure: None Work Experience: At least 4 years of experience working in regulatory affairs for medical devices. Knowledge / Skills / Abilities: Ability to manage multiple projects and work in a fast paced, changing environment. Advance skills in Word and Excel. Strong understanding of medical device regulations for pre-market approvals/clearances for medical device. Understanding of post- market regulatory requirements of medical device. Skill and ability to diagnose, isolate, and resolve complex issues and recommend and implement strategies to resolve problems. Requires the ability to present and communicate with various audiences (e.g. senior management and non-technical audiences). Position requires up to 15% travel

Preferred Job Requirements

• Education: None Certification / Licensure: RAC Certification. Work Experience: Experience working with SAP. Knowledge / Skills / Abilities: Experience writing 510(k)s and CE technical files. Experience directly managing people including hiring, developing, motivating, and directing people as they work. Experience applying knowledge of EPA VOC, Prop 65, FIFRA, OSHA HAZCOM, CPSC, DOT, FDA, and/or VAWD.

Salary

The anticipated salary range for this position: $116,000.00 - $174,000.00 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.

Benefits

• 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.

Company Culture and Inclusion

• 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.

Additional Information

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.