Senior Regulatory Affairs Manager

Werfenlife SA.; Bedford (TX); On-site; USD 80,000 - 120,000; Full time

Job summary

An innovative and growing company is seeking a Regulatory Affairs Manager to lead a team focused on maintaining compliance with US FDA and international regulations. This role involves overseeing post-market regulatory activities, managing adverse event reporting, and ensuring adherence to medical device regulations. The ideal candidate will have a strong background in regulatory management within the medical device industry, with at least 7 years of experience. Join a family-owned firm dedicated to quality and innovation, where your expertise will contribute to critical advancements in specialized diagnostics. If you thrive in a challenging environment and are passionate about regulatory affairs, this opportunity is for you.

Qualifications

• 7+ years of management experience in the medical device or IVD industry.
• Experience with US FDA and Health Canada regulations required.

Responsibilities

• Manage regulatory team for compliance with US FDA and international regulations.
• Oversee post-market requirements and adverse event reporting.

Skills

Regulatory Management

Adverse Event Reporting

Risk Analysis

Medical Device Regulations

Post-Market Surveillance

Education

Bachelor's Degree in Regulatory or Science Related Areas

Tools

FDA Regulations

Health Canada Regulations

ISO 13485

Job description

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country: United States

Shift: 1st

About the Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.

Overview

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.

Responsibilities

Key Accountabilities

• 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.

Essential Functions:

• 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 timelines (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.
• 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.

Qualifications

Minimum Knowledge & Experience Required for the Position:

• 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.

Travel Requirements: Some travel required up to 20%.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace.