Regulatory Affairs Manager

Job Description

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:

• Supports external & internal audits and inspections as required.
• Aware of and complies with the RWMIC Quality Manual and regulations & requirements as they apply to this job type/position.
• Completes all planned Quality & Compliance training within the defined deadlines
• Other duties as assigned by US Head of Regulatory and Quality Assurance.
  
  

QUALIFICATIONS:

• B.S. Degree in an engineering, life science or health-based discipline.
• Minimum 5 years medical device Regulatory Affairs experience in both pre and post market activities.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams at all levels.
• Strong time management skills, ability to prioritize workloads, and organizational skills.
• Excellent attention to detail and accuracy.
• Experience with filing 510k’s or equivalent experience registering medical devices outside the US.
• Accredited Medical Device certifications: ASQ, RAPS, AAMI, ISO, etc. preferred.
• Intermediate-Advanced PC skills with all MS Office suite products.
• The following physical demands are required:
• Stand/Sit/Walk 8 hours per day
• The following work environment conditions may exist:
• Infectious Disease Exposure
• Chemicals Exposure
• Experience with and understanding of cross-cultural differences and the ability to work within this environment is crucial for successful employment.
• RWMIC offers annual Immunizations for Hep B and Flu Shots to all RWMIC employees. RWMIC employees have the responsibility to themselves and the company to consider receiving these immunizations.
• All RWMIC Employees have the responsibility to themselves and the company to work safely.
  
  

EEO Statement

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

• 401 (k) Retirement Savings Plan and Trust w/Matching Program
• Medical Insurance, Dental and Vision Insurance
• Company Paid Life & Disability Insurance
• Paid Time Off
• Paid Parental Leave
• Telecommuting
• Flexible Schedules
• Tuition Reimbursement
• Wellness Program
• Flexible Spending Accounts
• Unpaid Time Off
  
  

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.