Regulatory Affairs Specialist

Location: Selangor, Malaysia

Circulation

At ZOLL, we're passionate about improving patient outcomes and helping save lives.

We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Circulation division of ZOLL Medical Corporation is focused on "beating heart" therapies for hospitals. Post-cardiac arrest, STEMI heart attack, and severe fever are some of the applications of ZOLL's unique devices. Fully integrated, ZOLL Circulation researches, develops, manufactures, and sells novel technologies includes ZOLL Temperature Management Solutions and TherOx SSO2 Therapy. Temperature Management Solutions empower physicians to "prescribe" a temperature and achieve it. TherOx SSO2 Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks.

Job Summary
Responsible for preparing regulatory submissions in the APAC region required to market new or modified devices including all relevant maintenance activities.


Essential Functions

  • Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals for the APAC region- such as CFDA/TFDA/HSA/MDA, CDSCO, MFDS.
  • Represent regulatory affairs on project/product teams, e.g.: labelling, risk management, and design review meetings.
  • Working with department management & providing regulatory guidance and guidance on applicable standards to cross-functional groups.
  • Working with department management provides APAC regulatory strategies and regulatory plans.
  • Working with department management, communicating with APAC regulatory authorities.
  • Coordinates/prepare and maintains regulatory notifications within the APAC region.
  • Coordinates/prepare and maintains APAC files in accordance with the specific in-country regulations for the APAC requirements, manages and ensures timely updates for all applicable APAC certifications.
  • Coordinates and prepares responses to regulatory agencies or other such regulatory agency letters.
  • Supports Reviews of product labeling changes
  • Reviews promotional literature and marketing materials
  • Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory 
  • authorities that may impact the company.
  • Participates in regulatory audits/inspections as required
  • Writes SOPs and train key personnel as needed
  • Comply with all policies and standards.
  • Any other job responsibilities as assigned by management and subject to modification.


Required/Preferred Education and Experience

  • 2-3 years of regulatory experience in the Medical Device Industry preferred
  • Experience with medical device regulatory submissions with CFDA, HSA, TFDA, MDA, CDSCO, MFDS preferred
  • Previous experience working with APAC Regulatory Authorities relative to premarket and compliance activities preferred.
  • Experience with medical device submissions preferred.
  • Degree in Regulatory Affairs or Regulatory Affairs Certification preferred


Knowledge, Skills and Abilities

  • Project management skills
  • Degree in RA or Regulatory Affairs Certification a plus
  • Must be able to work under pressure to meet regulatory reporting time frames and company requirements
  • Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
  • Knowledge of U.S. and European/International regulations and standards
  • Experience interacting with FDA and/or other regulatory agencies
  • Must work well in team environments
  • Must demonstrate leadership skills in team setting.
  • Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scope
  • Solid understanding of manufacturing and change control, and an awareness of regulatory trends
  • Understanding of engineering concepts and scientific terminology
  • Superior interpersonal skills
  • Excellent communication skills, both oral and written
  • Proven ability to prioritize, conduct, and manage time to meet project deadlines
  • Documented evidence of writing skills
  • Basic understanding of computer applications
  • Familiarity with medical terminology a plus


Travel Requirements

  • 10% travel required


Physical Demands

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.

  • Standing - Occasionally
  • Walking - Occasionally
  • Sitting - Constantly
  • Talking - Occasionally
  • Hearing - Occasionally
  • Repetitive Motions - Frequently


ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.