Regulatory Affairs Specialist II

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Job description

Epredia, a global leader in providing solutions for cancer diagnostics, is dedicated to improving lives by enabling our customers to achieve diagnostic excellence. We're growing quickly and constantly expanding our team. Find a rewarding career with a diverse group of individuals that share a passion to do work that matters and positively impacts patient lives.
Title: Regulatory Affairs Specialist II

Summary of position: The Regulatory Affairs Specialist II reports to the Sr. Manager, Regulatory Affairs (Americas) and is responsible for regulatory guidance and daily functional support of site activities. Participation with premarket and post market activities for Class I IVD medical devices will be required. This position requires a highly organized individual who enjoys cross-functional collaboration but is able to work independently in a fast paced work environment with limited supervision. This individual should be strategic and be able to multi-task and adapt to the ever changing regulatory environment.

Key Responsibilities:

• Manage daily regulatory functions for the site commercial organization
• Update FDA website annually or as needed for Kalamazoo site
• Work cross-functionally to develop and maintain product technical files
• Serve as site regulatory resource for daily activities with internal cross-functional teams including quality system support, change control, and management review

• Review marketing materials and production artwork for labeling and regulatory claims
• Ensure regulatory review and approval of appropriate customer communications
• Provide regulatory guidance pertaining to Class I IVDs and labeling requirements
• Collaborate cross-functionally to evaluate product complaints and make regulatory determinations on subsequent activities including Health Hazard Assessments
• Participate in post market activities including recall and adverse event reporting

• Participate as a regulatory resource on New Product Development teams and work with external teams to support premarket activities including development of regulatory strategy
• Provide regulatory information and guidance for product development and planning throughout the product life cycle to the regulatory groups and others within the organization
• Develop, prepare and update departmental Standard Operating Procedures
• Provide support for International Regulatory team with new and existing registrations
• Collaborate with International Regulatory team to ensure product line is compliant with domestic and international regulation

Required Qualifications:

• Bachelor's Degree in Science related study
• A minimum 2 plus years regulatory experience
• 3-5 years of experience in medical device, biotech or pharmaceuticals ideal.
• General understanding of product development and design control
• Understanding of FDA and international medical device regulations
• Ability to analyze and resolve non-routine regulatory issues using independent judgment
• Advanced PC skills with proficiency in Microsoft Office Suite, including Excel

YOUR APPLICATION:

Epredia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.

TO ALL RECRUITMENT AGENCIES:

Epredia does not accept unsolicited third party resumes.

Epredia is an Equal Opportunity Employer including Disability/Protected Veterans.

Our Journey. Epredia is on a journey to create an inclusive environment where we celebrate multiple approaches and points of view. Our goal is to attract, develop and retain the best and brightest from all walks of life and backgrounds. Your candidacy will be reviewed regardless of race, religion, gender, sexual orientation, national origin, disability, age or veteran status.