Careers

QA/RA Associate

Job Title: QA/RA Associate

Job Type: Part to full-time, hybrid on-site and remote

Note: This position is a job share with current QA/QMS Director

Description: The QA/RA Associate is responsible for maintenance of the quality system; product technical files and submissions, certification renewals, periodic updates and registrations to regulatory agencies; review of product and regulatory changes for impact on regulatory filings; research of regulatory issues to provide guidance and advice to senior management.

 

Specific Duties and Responsibilities :

  • Medical device product line responsibilities:
    • Maintenance of product technical files
    • Maintenance of current product approvals and registrations, including initiation of product testing as necessary to maintain approvals: sterilization, biocompatibility, shelf life stability, etc
    • New product submissions
    • Support of international distribution partners with required reports and documentation for product approvals and registrations in their markets
    • Post-market surveillance activities, including regulatory reviews of customer complaints and determination of regulatory reportability, advisory notice or recall as applicable
    • Advice to executive management on impact of regulation changes, strategies for compliance
    • Regulatory guidance to development project teams regarding design, development, evaluation, and marketing of products
    • Maintenance of company and product information in GUDID, and EUDAMED databases
    • Risk Management, incorporating new inputs into risk analysis and risk assessment
    • Review of labeling, advertising, and marketing materials for compliance to regulatory requirements
    • Quality management system responsibilities:
      • Establishment and maintenance of the quality system in compliance with the requirements of FDA QSR, ISO 13485, EU MDR.
      • Internal Audits
      • Preparation of Management Reviews, including compiling, analyzing, trending and presenting data and QMS metrics
      • Participation in vendor evaluation, selection, and performance evaluation.
    • Other duties as assigned

     

    Requirements:

    • BA degree in a science or related field
    • Minimum 5 years’ experience in medical device regulatory affairs
    • Strong working knowledge of US and EU medical device regulations
    • Strong working knowledge and experience with quality systems regulations (FDA QSR, ISO 13485, EU MDR)
    • Self-Management: possesses integrity, flexibility, good use of time.
    • Good communication skills, both verbal and written
    • Effective project management and problem-solving skills
    • Good organizational ability and strong attention to detail

    To apply please submit the following to hr@lifescienceplus.com

    • Resume

    Independent Medical Sales (1099) Representative

    Requirements

    • Expertise: Medical-Surgical Specialties – Burns, Wound Care, Hemostasis, Cardiac Cath. or Interventional Laboratory
    • Salary: Very Competitive Commission Sales Program
    • Job Type: Full Time and Part Time or Contractor
    • Location: All US territories
    • Job Level: Medical Device Sales (Minimum 3-5 years)

    Job Description

      We are a quickly expanding biomedical device company based in Mountain View, California. Now, we are looking for sales driven and goal-oriented outside sales to represent our well-established brand. Our Independent Sales Representatives are responsible for generating new business, identifying new opportunities by visiting customers such as hospitals, trauma centers, first responders, dental clinics, etc., and selling our products through the achievement of opportunity. The Independent Sales Representative will reach his or her business targets through effective management of designated territories and physical visits to customer sites. This individual will also develop ongoing, profitable relationships with customers and continually maintain a professional image.

    Educational Requirements

    Medical sales experience preferred -3+ years of experience in sales required (outside sales required)

    -Must be sales driven, as this position is 1099 and commission only

    Job Responsibilities

    • Ability to promote and sell our company’s products in wound care market
    • Prior pharmaceutical or medical sales experience is strongly preferred
    • Maintain detailed sales and marketing records for all accounts and use them to plan, execute and evaluate sales calls
    • Develop productive business relationships with all customers; must be able to uncover and understand customers’ needs while providing responsive customer service at all times
    • Emphasize product/service features and benefits, quote prices, and prepare sales order forms and/or reports
    • Responsible for providing accurate and timely communication to management of sales and market-related issues affecting successful performance
    • Responsible for keeping current on all training initiatives, product knowledge and sales training; staying up-to-date on industry trends
    • Able to work from home as your base Working Conditions
    • Ability to travel to, attend, and conduct presentations

    To apply please submit the following to hr@lifescienceplus.com

    • Resume

    GSA Medical Sales Representatives

    LifeScience PLUS is looking for experienced Independent Sales Representatives (1099 commission only) in all major U.S. cities to generate sales of our revolutionary wound care products in hospitals, trauma centers, wound care clinics, dental clinics, etc.

    LifeScience PLUS has products on the GSA Schedule (Contract #V797D-70261) and an approved DLA-DAPA contract (SP0200-16-H-0005)which give Representatives easy access to the VA Health System, Military Healthcare Network and other GSA Schedule user agencies.

    What We Offer

    High Commission and Unlimited Earning Opportunity!!

    Required Skills

    • Proven successful sales experience.
    • Outstanding communication skills.

     

    Job Responsibilities

    • Promote and sell LSP products in wound care markets.
    • Service existing accounts, obtain orders, develop and establish new accounts.
    • Train doctors and hospital staff to become proficient in using our BloodSTOP hemostatic products.
    • Build and execute sales plan.
    • Attend local or national conferences as needed.
    • Travel to, attend, and conduct presentations as required.

     

    Educational Requirement

    • College degree.
    • Minimum of 3+ years medical device or pharmaceutical sales experience.

     

    To apply please submit the following to hr@lifescienceplus.com

    • Resume

    Inside Sales/Product and Marketing Representative

    Requirements

    • Expertise: Sales
    • Education: Bachelor’s Degree
    • Job Type: Full Time and part time or contractor
    • Location: Mountain View, CA
    • Job Level: Experienced

     

    Position Summary

    The Inside Sales/Product and Marketing Representative is responsible for the day-to-day execution of marketing communications projects related to the promotion of BloodSTOP and BloodSTOP iX product portfolio, ensuring the successful and timely completion of projects within established schedules and budgets. The Inside Sales/Product and Marketing Representative is a highly organized, motivated problem-solver capable of working with minimal supervision. This individual should be detail-oriented, enjoy multi-tasking, and thrive in a creative, dynamic, and fast-paced environment. He/she will need to exercise mature judgment while interacting extensively with internal and external clients. The candidate will also participate with the Product Management and Product Marketing teams in the development of plans for product promotion in support of marketing objectives for multiple new and existing integrated campaigns.

    To apply please submit the following to hr@lifescienceplus.com

    • Resume

    Independent Sales Representatives (First Aid Kits/EMS/Fire/Police)

    LifeScience PLUS is looking for experienced Independent Sales Representatives (First Aid Kits/EMS/Fire/Police)(1099 commission only) to generate sales of our revolutionary wound care products in the relevant facilities.

     
    What We Offer:

    High Commission and Unlimited Earning Opportunity!!

    Required Skills:

    • Proven successful sales experience in First Aid Kits/EMS/Fire/Police
    • Outstanding communication skills.

     

    Job Responsibilities:

    • Promote and sell LSP products.
    • Advanced knowledge of sales, account management, forecasting and marketing.
    • Good Knowledge of Medical technology.
    • Service existing accounts, obtain orders, develop and establish new accounts.
    • Build and execute sales plan.
    • Travel to, attend, and conduct presentations as required.

     

    Educational Requirement:

    • College degree.
    • Minimum of 3+ years in First Aid Kits/EMS/Fire/Police sales experience.


     
    To apply please submit the following to hr@lifescienceplus.com

    • Resume