Regulatory Affairs Manager

Responsible for ensuring FDA regulatory requirements are met for new product introductions and compliance with establishment and product registrations for RWMIC. Manages the post market process under 21 CFR Part 806.

REQUIREMENTS AND RESPONSIBILITIES :

• Oversees and / or executes the creation and submission of 510(k)s, Letters to File (LTF) and associated labeling.
• Ensures timely, appropriate, and complete communication with FDA and other regulatory bodies for premarket and post market activities.
• Leads preparation of external audits. Acts as main company spokesperson during external audits.
• Ensures the preparation and submission of Device Listings and facility registrations.
• Leads Recall and associated field action activities.
• Supports Quality team for regulatory requirements such as FDA Quality System Regulation, 21 CFR 820 & ISO 13485.
• Partners with RW GmbH Regulatory and R&D teams to develop and submit 510k submissions.
• Conducts Regulatory intelligence to gather current and changing requirements. Reports key findings to manager on a regular basis.
• Reviews quality data sources and communicates actionable trends that require further evaluation or investigation.
• Reviews and approves device labeling changes and updates. Manages the Regulatory Affairs team which includes hiring, performance management, training and career development.
• Oversees creation and maintenance of vendor Quality Agreements.
• Conducts training in Quality System Regulation, ISO Standards, and other International Regulations.
• Participates in CAPA activities as needed
• Develops processes and procedures for Regulatory and assures their implementation.

ADDITIONAL RESPONSIBILITIES :

QUALIFICATIONS :

Stand / Sit / Walk 8 hours per day

Infectious Disease Exposure

EEO Statement

We offer competitive wages and a comprehensive benefits package, which includes :

At Richard Wolf, we believe in creating a workplace where everyone has the opportunity to thrive. We are committed to providing equal employment opportunities to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, status as a protected veteran, or any other legally protected status. We celebrate diversity and welcome all qualified candidates to apply for open positions.