Regulatory Affairs Specialist

1 week ago

Kuala Lumpur, Kuala Lumpur, Malaysia Zoll Medical Corporation Full time

Regulatory Affairs Specialist:

Location:

Remote, Remote:

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.


Job Summary


The Senior Regulatory Affairs Specialist is responsible for preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.


Essential Functions

  • Support in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
  • Represent regulatory affairs on project/product teams, risk management, and all design review meetings.
  • Work with department management provides regulatory guidance and guidance on applicable standards to crossfunctional groups.
  • Work with department management provides global regulatory strategies and regulatory plans.
  • Work with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities.
  • Coordinate/prepare and maintain FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements.
  • Coordinate/prepare and maintain CE files in accordance with current Medical Device Directive requirements, manages Essential Requirement checklists and ensures timely updates for all applicable CE certifications.
  • Coordinate and prepare responses to FDA/NB or other such regulatory agency letters.
  • Support Reviews of product labeling changes.
  • Review promotional literature and marketing materials.
  • Support CAPA and CAPA closure.
  • Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company
  • Participate in regulatory audits/inspections as required.
  • Write SOPs and train key personnel as needed.

Required/Preferred Education and Experience

  • Bachelor's Degree required
  • 6+ years of regulatory experience in the Medical Device Industry required and
  • Experience with medical device regulatory submissions (510(k) or PMA) required and
  • Previous experience working with Regulatory Authorities relative to premarket and compliance activities. required and
  • Experience with medical device submissions required

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 mínimal 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.
  • 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
  • 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.

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