Overview

Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Job Summary

Regulatory Affairs Associate III supports the regulatory department by assisting with activites in support of global product registrations and new regulation implementations, and proessing of product restrictions. The individual in this position will be working both independently and in a team-oriented environment. This individual performs routine product registrations/submissions and general administrative/documentation activities. This position works under the guidance of Regulatory Specialists and direction of management, while using independent judgement and decision making to carry out daily tasks and assigned projects. Ensures all responsibilities are carried out are carried out in accordance with established standard operating procedures (SOPs), policies and applicable regulations and standards.

Responsibilities

Key Accountabilities

• Completes international registrations by assembling/creating technical documentation/dossiers as requested by Werfen Affiliate/distributors.
• Supports and performs activities to obtain global market authorization in domestic and international geographies including submissions, registrations, apostilles, declarations, license applications, attestations, certifications, design dossiers, and technical documentation, export certificates, and device listings.
• Assembles and maintains product technical documentation and ongoing activities related to compliance with global regulatory directives and regulations. Create records in central repository of market authorization deliverables and responses.
• Provides support to the Regulatory team to resolve potential regulatory issues, deficiencies, and questions from regulatory agencies.
• Compiles, enters, and verifies data accuracy of product and company information in internal and external regulatory databases.
• Performs moderate to complex on-line research for regulatory standards, requirements, guidance, journal articles and provide regulatory findings to teams as needed.
• Supports Regulatory Specialists with authoring regulatory plans and strategies.
• Proofreads and publishes regulatory documents.
• Manage product restrictions/releases in SAP based on product's approval status.
• Writes, revises, and formats documents such as Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Initiates change orders for department documentation and records.
• Provides administrative support for audits, as needed.
• Completes, organizes, reviews, maintains, and archives records.
• Performs other duties and projects as assigned to meet company and department objectives.
• Complies with applicable SOPs, ISO, FDA, and other applicable Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources, and all other regulatory and company policies.
• Reflects Werfen Values in both quality of work and in working relationships.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

• Quality teams (Assurance, Engineering, and Systems)
• Regulatory teams (Compliance, Affairs, and Operations)
• Manufacturing teams
• Werfen Affiliates
• Research & Development teams, including Manufacturing Technical Service (MTS)
• Supply Chain teams

Qualifications

Minimum Knowledge & Experience:

• Bachelor’s degree in a life science, engineering, or related field required.
• At least five (5) years of work experience in in vitro diagnostic (IVD) or medical device (MD) industry of which two (2) should be within Regulatory Affairs.
• Working understanding in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations and post-market vigilance, preferred.
• Experience with domestic and international submissions preferred.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Working knowledge of electronic publishing/file management system.
• Working ability to successfully manage multiple tasks.
• Working ability to solve simple to moderate complexity problems and deal with a variety of concrete variables in situations where only limited standardization exists required.
• Proficiency in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point preferred
• Strong attention to detail including proofreading.
• Good written and oral communication skills.
• Proactive and results oriented.
• Ability to read and follow Standard Operating Procedures (SOPs).

Travel Requirements: 

• None

The salary range for this position is currently $80,000-$95,000 annual. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.

Work Environment (US only): 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect information. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard and telephone. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is active and requires varying levels of mobility.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com