Regulatory Specialist Position Available In Broward, Florida

Regulatory Specialist Advantage Medical Electronics, LLC 11705 NW 39th Street, Coral Springs, FL 33065

Job Title:

Regulatory and Post Market Surveillance (PMS)

Specialist Department:

Quality Reports to:

Quality and Regulatory Affairs Manager FLSA Exempt SUMMARY:

The Regulatory and PMS Specialist is responsible to support for LifeSync’s regulatory approval to market medical devices. This includes assessment of device/labeling and quality management changes for regulatory implications. Additionally, this position is responsible for post market surveillance (PMS) activities, including complaints reportability assessment, investigation, trending, and development of PMS plans/reports. The position works closely with Engineering, Manufacturing, Quality and Marketing, ensuring products can be deployed within the marketplace and identifying risks, improvement based of post market data. This person is key in supporting marketing strategies and safe, effective, quality products. This position will support the organization obtain all necessary certifications, ensure our products are built consistent with industry standards/regulations, as well as our quality management system (QMS). This is a role that requires broad knowledge in Regulatory and QMS requirements.

DUTIES AND RESPONSIBILITIES

Provides pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Agencies. Perform product and QMS regulatory reviews due to standards/regulations/ product changes or new market introduction. Evaluate complaint information and perform reportability decisions. Investigate complaints and perform trending and analysis. Perform post market surveillance activities (PSURs (Periodic Safety Update Reports) and PMSRs (Post-Market Surveillance Reports)) per EUMDR and Health Canada requirements. Support internal/external audits. Perform other related duties, as assigned.

REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Demonstrated process development and problem-solving skills. Ability to multi-task in an environment where responsibilities tend to encompass more than the job title would indicate. Understand US FDA, Health Canada, EU, LATAM, UK CA requirements. Able to develop and maintain mutually respectful, cooperative working relationships with co-workers, customers and suppliers while promoting a positive company image. Experienced in Microsoft Office, ERP system experience, Microsoft Project.

SUPERVISORY RESPONSIBILITIES

Not Required

EDUCATION AND/OR EXPERIENCE

Associate degree 2 + years of Medical Device Functional Experience (Quality, Clinical, Engineering, Regulatory or equivalent). Experience with US 510k, Health Canada, International Device Submissions, Licensing and Registration

PHYSICAL DEMAND

The position is a sedentary job. The person must be comfortable sitting at a desk for long periods of time.

WORK ENVIRONMENT

The work environment is a typical office environment.

TRAVEL REQUIREMENT

Not Required The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.