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Senior Regulatory Affairs Engineer

Job Description

The LifeVest division of ZOLL Medical Corporation is dedicated to developing the LifeVest wearable defibrillator (WCD) and associated technologies. The LifeVest WCD, worn directly against a patient’s skin, is prescribed to patients at risk of sudden cardiac death (SCD). Every year, 350,000 American lives are lost to SCD. At ZOLL LifeVest, your work will help to ensure cardiac patients get the life-saving therapy they need.

We’ve been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL LifeVest the ideal place to build your career. 

Position Summary:  This senior-level position will develop comprehensive 510(k), De Novo, and PMA applications.  The position will provide expertise, recommendations, and regulatory direction for current and new product development, advertising and promotional materials, and product design or manufacturing modifications.

Essential Duties and Responsibilities:

  • Prepare and submit 510(k) and De Novo applications to FDA and collaborate directly with FDA reviewers to gain marketing approval.
  • Prepare and submit IDE and PMA applications, PMA supplements, and periodic reports to FDA and collaborate directly with FDA reviewers to gain approval.
  • Prepare and submit international device applications and collaborate directly with consultants/reviewers to gain marketing approval.
  • Coordinate with ZOLL’s domestic and international business units for device clearance in the intended markets.
  • Coordinate with medical experts to develop periodic Clinical Evaluation Reports per MEDDEV 2.7/1 Rev 4.
  • Conduct various risk analysis activities for new and existing products including FMEAs.
  • Investigation of medical device complaints and, prepare and submit corresponding incident reports to FDA and/or international regulatory bodies for device malfunctions and adverse events.
  • Prepare, submit, and coordinate product recall notifications, advisory reports, and incident reports.
  • Performs other duties as assigned by Management.

Supervisory Responsibilities:  None.

Qualifications:  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.

Education and/or Experience and/or Skill:

  • Bachelor's degree in Bio-Engineering/Biomedical Engineering is required; Master’s degree preferred.
  • At least a 5 year track record of successful 510(k) device clearance and/or De Novo grants, preferably in the Cardiac space.
  • At least a 5 year track record of successful international device approval, preferably in the Cardiac space.
  • PMA experience is preferred.
  • Must have a strong understanding and application of FDA’s consensus standards and guidance documents.
  • International medical device regulation experience preferred.
  • Strong project and time management skills to meet deadlines.
  • Strong experience working with Microsoft Office Suite.
  • MS Access database experience preferred.                                                            

Language Skills:  Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills:  Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:  Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Work Environment:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • The noise level in the work environment is usually quiet.

ZOLL is an Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.

#CB

#MM1

Job Requirements

 

Job Snapshot

Location US-PA-Pittsburgh
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace
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Company Overview

ZOLL LifeVest

At ZOLL LifeVest, we seek to revolutionize the prevention of sudden cardiac arrest, the single largest cause of death in the United States. We’re experiencing rapid growth, and as a result, ZOLL if looking for talented and dedicated team members of all levels. We offer the challenge of working in a fast-paced, team environment where your energy and expertise can help you reach your full potential while developing, supporting, or marketing leading-edge technology, products, and services. Learn More

Contact Information

US-PA-Pittsburgh
Snapshot
ZOLL LifeVest
Company:
US-PA-Pittsburgh
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace
Store Type:

Job Description

The LifeVest division of ZOLL Medical Corporation is dedicated to developing the LifeVest wearable defibrillator (WCD) and associated technologies. The LifeVest WCD, worn directly against a patient’s skin, is prescribed to patients at risk of sudden cardiac death (SCD). Every year, 350,000 American lives are lost to SCD. At ZOLL LifeVest, your work will help to ensure cardiac patients get the life-saving therapy they need.

We’ve been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL LifeVest the ideal place to build your career. 

Position Summary:  This senior-level position will develop comprehensive 510(k), De Novo, and PMA applications.  The position will provide expertise, recommendations, and regulatory direction for current and new product development, advertising and promotional materials, and product design or manufacturing modifications.

Essential Duties and Responsibilities:

  • Prepare and submit 510(k) and De Novo applications to FDA and collaborate directly with FDA reviewers to gain marketing approval.
  • Prepare and submit IDE and PMA applications, PMA supplements, and periodic reports to FDA and collaborate directly with FDA reviewers to gain approval.
  • Prepare and submit international device applications and collaborate directly with consultants/reviewers to gain marketing approval.
  • Coordinate with ZOLL’s domestic and international business units for device clearance in the intended markets.
  • Coordinate with medical experts to develop periodic Clinical Evaluation Reports per MEDDEV 2.7/1 Rev 4.
  • Conduct various risk analysis activities for new and existing products including FMEAs.
  • Investigation of medical device complaints and, prepare and submit corresponding incident reports to FDA and/or international regulatory bodies for device malfunctions and adverse events.
  • Prepare, submit, and coordinate product recall notifications, advisory reports, and incident reports.
  • Performs other duties as assigned by Management.

Supervisory Responsibilities:  None.

Qualifications:  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.

Education and/or Experience and/or Skill:

  • Bachelor's degree in Bio-Engineering/Biomedical Engineering is required; Master’s degree preferred.
  • At least a 5 year track record of successful 510(k) device clearance and/or De Novo grants, preferably in the Cardiac space.
  • At least a 5 year track record of successful international device approval, preferably in the Cardiac space.
  • PMA experience is preferred.
  • Must have a strong understanding and application of FDA’s consensus standards and guidance documents.
  • International medical device regulation experience preferred.
  • Strong project and time management skills to meet deadlines.
  • Strong experience working with Microsoft Office Suite.
  • MS Access database experience preferred.                                                            

Language Skills:  Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills:  Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:  Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Work Environment:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • The noise level in the work environment is usually quiet.

ZOLL is an Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.

#CB

#MM1

Job Requirements

 
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