International Regulatory Affairs Manager II (Asia)

08 Jul, 2022

Jobs

International Regulatory Affairs Manager II (Asia)

Werfen
Bedford, MA

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.

 

Position Summary

Position requires a qualified, highly motivated, experienced individual, within our Regulatory Affairs group to report into the Senior Regulatory Affairs Director.  This individual will be responsible for providing strategic regulatory leadership for the company in key Asia markets (e.g. China and Japan).  In respect to these key Asia markets, the person will provide direction to R&D on test requirements for market entry, as well as to work with multiple departments within the organization on product modifications when needed, prepare regulatory documentation for submissions and renewals to regulatory agencies (e.g. NMPA, PMDA), review labeling for regulatory compliance and provide on-going strategic direction and education to the Company on regulation changes.

Responsibilities

Key Accountabilities:

  • Act as direct liaison with the in-country Regulatory Teams in China and Japan, as well as the International Regulatory Team for support activities in other Asia countries.
  • Provide strategic content for Worldwide Regulatory Plans and Determinations to define test and documentation requirements for key Asia markets .
  • Participate in applicable design team meetings to provide International regulatory guidance and perspective on Asia requirements, and support the key Regulatory project team lead, with the direction and requirements for the particular countries.
  • Review and approve technical documentation including protocols, technical reports, and specifications to assure conformance with Asia regulations.
  • Guide and lead the initiative for timely preparation of high quality regulatory submissions and renewals, and supporting responses to questions for all products in the key Asia markets.
  • Manage the registration (and as applicable for amendment and renewal) of IL-labeled and OEM product in Asia, in collaboration with the in-country Regulatory Team and, as appropriate, with the International Regulatory Team.
  • Participate on labeling generation/evaluation teams to ensure labeling compliance with Asia market regulations.
  • Remain informed and provide guidance on changes/updates to regulations in Asia and assess and report to management on their impact to on-market product and product in development.
  • Support Senior RA Director and International Regulatory Team on other related projects, as needed.

Internal Networking/Key Relationships

This individual needs to develop relationships working with the domestic and International Regulatory and R&D teams, as well as Marketing and Operations.

 Skills & Capabilities:

  • Leadership
  • Effective decision maker
  • Act as advisor and educator to Company on Asia regulations and requirements
  • High cultural awareness and sensitivity

Qualifications

Min Knowledge & Experience required for the position:

  • Requires a Bachelor degree, preferably in a science discipline; Master’s degree preferred
  • Minimum of 10-year experience in the medical device industry (in vitro diagnostics a plus)
  • Minimum of 5-year experience in a management position
  • Experience in registering product in Asia markets, specifically China market preferred
    Working knowledge of China and Japan medical device regulations; other countries within Asia preferred
  • Effective verbal and written communication in individual and group settings
  • Able to work with minimal supervision and in a pressurized environment
  • Language fluency: English essential and Chinese preferred but not required

 

International Mobility:

  • Required: yes

Travel requirements:

  • Approximately 10% of time per year, domestic and international

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

Job posted: 2022-07-08