Senior Regulatory Affairs Manager

Position Summary

Responsible to manage a regulatory team to oversee all aspects of the pre-market or post-market regulatory activities required to maintain compliance to US FDA, Health Canada, European IVD Directive 98/79/EC and European IVD Regulation (EU) 217/746, MDSAP country regulations, as well as other country regulatory agencies. Provides regulatory leadership to the Company reporting to executive management on the status of pre- and post-market projects.

• Post-market RA Manager: Provides regulatory oversight on all aspects of post-market requirements, including but not limited to the management of field corrections and removals, worldwide vigilance reporting, device modification assessments for registration requirements and management of the post-market surveillance program to ensure compliance with applicable domestic and international regulations.
  
  

Responsibilities

Key Accountabilities

Essential Functions

Post-market RA Responsibilities (as assigned):

• Acts as the regulatory lead on the risk analysis worksheet (RAW) reviews for on-market product to identify potentially reportable incidents and field corrections/removals.
• Leads the regulatory team that supports QA/RA Milan offices and Werfen affiliate offices for adverse event filings and responses to EU Competent Authorities in compliance with MEDDEV 2.12-1.
• Oversees the timely filing of adverse events in the United States and Canada and ensures that the affiliate countries file adverse events per local regulations and time lines (e.g. Australia, Brazil, Japan and S. Korea).
• Manages all aspects of field corrections and removal for on-market product, authoring field communications, orchestrating the timely notification of customers and regulatory agencies (as required), preparing regulatory strategy, overseeing the team that assembles necessary support documentation and product information. Interfaces directly with US FDA and Health Canada and supports local affiliates and dealers in meeting their country regulations and time lines.
• Leads the regulatory team in the assessment of device modifications to IL-labeled medical devices, filing with US FDA and Health Canada directly (as needed), ensuring that necessary country regulatory filings are made prior to implementation in compliance with their local regulations (e.g. Australia, Brazil, Japan and S. Korea).
• Leads the post-market surveillance program in compliance with worldwide regulatory requirements.
• Leads team that maintains FDA establishment registrations and device licenses, UDI database, Canadian license renewals and updates Health Canada in the event of a change in the ISO certificate per US and FDA regulations.
• Leads team that works with local affiliates in Australia, Brazil and Japan to ensure MDSAP country regulatory requirements are met and the documentation is available.
• Reviews and signs Change Orders for on-market product.
• Develops and maintain regulatory related post-market procedures/policies.
• Other areas as needed to meet worldwide regulations.
  
  

Budget Managed (if applicable):

• N/A
  
  

Internal Networking/Key Relationships:

• All Werfen departments in multiple locations. Affiliate and Sister Division interface.
  
  

Skills & Capabilities:

• Effective verbal and written communication in individual and group settings, with proven experience authoring regulatory submissions or field communications
• Very detail oriented, with solid organizational skills and the ability to meet deadlines
• Able to manage competing projects, with strong planning/prioritization skills
• Strong leadership skills, both at the direct report level and for interfacing with cross-functio nal departments, executive management and external regulatory agencies
  
  

Qualifications

Minimum Knowledge & Experience Required for the Position:

Post-market RA Manager

• Requires a Bachelor degree, preferably in regulatory or science related areas
• Minimum of 7 years of management experience in the medical device or IVD industry
• Experience with US FDA and Health Canada adverse event and field correction/removal regulations and guidelines required, with experience in international adverse event reporting and field correction/removal actions a major plus
• Experience in managing a post-market program preferred
• Knowledge of FDA 21 CFR 803, 806, 820, Health Canada Medical Device Regulation, European IVD Directive 98/79/EC and European IVD Regulation (EU) 217/746, MDSAP Companion Document and ISO 13485, preferred
  
  

International Mobility:

• Not required
  
  

Travel Requirements:

• Some travel required up to 20%