Manager Regulatory Affairs

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.
Responsible for leading the Regulatory Affairs team to develop regulatory strategies for domestic and international approvals of medical devices. Provide leadership and develop Regulatory Affairs professionals.

Job Description 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 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.

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…