Regulatory Affairs Specialist

2 weeks ago

Kuala Lumpur, Malaysia ZOLL LifeVest Full time

**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 cross-functional 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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