Regulatory Affairs Manager – Medical Devices (Hybrid)

Regulatory Jobs; 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 seeks a Manager Regulatory Affairs for the Eagan hybrid role to oversee regulatory strategies for medical devices domestically and internationally. You will lead the Regulatory Affairs team and interact with senior management and regulators to ensure compliance across pre- and post-market activities.

Requirements include a bachelor’s in Regulatory Affairs or related field, 4+ years in regulatory affairs for medical devices, RAC certification, and SAP experience, with up to

Qualifications

• Bachelor’s Degree in Regulatory Affairs, Life Sciences (e.g. biology, chemistry) or Engineering.
• At least 4 years of experience working in regulatory affairs for medical devices.
• Ability to manage multiple projects and work in a fast paced, changing environment.
• Advanced 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.

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 include: --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.

Skills

Project management

Excel

Regulatory knowledge

Problem solving

Communication

Travel 15%

Education

Bachelor's in Regulatory Affairs/Life Sciences/Engineering

RAC Certification

Tools

SAP

Job description

Medline Industries, LP seeks a Manager Regulatory Affairs for the Eagan hybrid role to oversee regulatory strategies for medical devices domestically and internationally. You will lead the Regulatory Affairs team and interact with senior management and regulators to ensure compliance across pre- and post-market activities.

Requirements include a bachelor’s in Regulatory Affairs or related field, 4+ years in regulatory affairs for medical devices, RAC certification, and SAP experience, with up to