Dohmen Life Science Services

Senior Regulatory Affairs Specialist

US-CO-Wheat Ridge
Job ID
2017-1781
# of Openings
1
Category
Quality Management Systems Services

Overview

OUR COMPANY:

 

Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most.  As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives. 

 

Our behavior is guided by five simple values –

Caring: We are empathetic and respectful.  We ask “how can I help you”

Committed: We are dedicated and persistent.  We ask “how can I make it happen”

Creative: We are inventive and imaginative. We ask “how can I do it better”

Collaborative: We are cooperative and share our knowledge. We ask “how can we achieve success” 

Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”

This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are essence of what makes us successful. They are what set us apart. 

 

 

THE POSITION:

The most important aspect of the position of the Tissue Services RA Manager is to contribute to DLSS’ internal Operations group (Outsourcing) and pertaining primarily to DLSS’ Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) customers. This position is responsible for supporting Donor Eligibility Clients with administrative functions, as well as with their donor eligibility programs ensuring that each donor eligibility customer is compliant with 21 CFR 1271 subpart C as they utilize DLSS’ web-based donor eligibility solution, the Donor Eligibility System (DES).  This is an all-encompassing tissue position including but not limited to donor eligibility.  This position may also manage the overall development and implementation of a client’s 21 CFR 1271 quality system.

POSITION SUCCESS FACTORS:

  • Ability to work with internal employees and external clients simultaneously
  • Ability to manage multiple projects and deliverables in a timely fashion
  • Ability to maintain customer and patient confidentiality. DLSS is considered by most DES customers to be a Business Associate under the Health Insurance Portability and Accountability Act (HIPAA).
  • Ability to understand the operation of the DES from various perspectives: client user, client administrator, DLSS administrator.
  • Ability to train new customers on the use of the DES.
  • Ability to communicate clearly with internal and external customers.
  • Ability to discern between system functionality issues and user issues, communicating each to management as appropriate.
  • Understanding of regulatory requirements of 21 CFR 1271 Subpart C, and their application.

 

ESSENTIAL FUNCTIONS:

  • Maintain DLSS’ donor eligibility web-based application and ensure regulatory compliance with 21 CFR 1271 subpart C and Part 11, including all internal and client administrative functions within the system.
  • Work with key customer personnel to ensure consistency of policies and procedures.
  • Assist in the training of new customers.
  • Manage multiple customer accounts as the primary donor eligibility coordinator.
  • Perform periodic audits of customer accounts to ensure proper use of the web-based application.
  • Support (as necessary) client’s quality representative including managing daily quality operations related to the Donor Eligibility process.
  • Facilitate the initiation and management all changes to the client 21 CFR 1271 quality system. This position must understand the total impact of any and all design changes to the quality system and the end product.
  • Assist with leading the design, structure, and implementation of the client’s 21 CFR 1271 quality system.
  • Continually evaluate day-to-day activities for process improvement opportunities
  • Provide support within Quality, Regulatory Affairs, and/or Regulatory Compliance Consulting Service Lines where necessary.
  • Provide training to DLSS Clients on 21 CFR 1271 regulations

 

Personal Skills/Attributes/Qualifications:

  • Ability to communicate the requirements of 21 CFR 1271 to customers including, but not limited to, physicians, nurses, administrative staff and, occasionally, patients/donors.
  • Ability to work within regulatory software, and become an expert in its operation
  • High attention to detail. Must be able to accurately evaluate hundreds of data points for each DES customer implementation.
  • Ability to manage multiple clients and project simultaneously.
  • Must be customer-service oriented. This position requires daily interaction with internal and external customers.
  • Ability to set aside personal opinion regarding the various patient/donor situations which are presented by DLSS customers.
  • Timeliness in achieving deliverables
  • Organizational skills
  • Excellent written and verbal communication
  • Able to work with direction that is not always specific, but asks for assistance if direction is not understandable
  • Able to explain reasoning that led to conclusions both orally and in writing

 

 

Responsibilities

 

Responsibilities:

  • Adherence to quality policies and SOPs as needed in a manner that creates total team buy-in.
  • Working independently under direct supervision to DLSS and indirect supervision to the client site.
  • Confidentiality of the entire donor process is kept at all times.
  • Compliance of the entire donor process is kept at all times.
  • Maintain Donor Eligibility System Templates in compliance with associated regulations
  • Maintain Tissue Quality System Templates in compliance with associated regulations
  • Notify Clients of changes within the Donor Eligibility System as a result of updates to maintain requirements with associated regulations
  • Provide accurate data, and assist with the month end billing process for the Donor Eligibility System

 

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

  • Bachelor’s degree in a related discipline with a minimum of 2 years of experience in the tissue, medical device, and/or pharmaceutical industries is required.
  • Two years of FDA regulatory and quality systems experience is highly desired.
  • Incumbent must be able to operate in a highly structured environment and manage multiple projects simultaneously among internal and external customers.
  • Incumbent must be able to demonstrate tact at all times while ensuring compliant behavior from the client.
  • Ability to understand and explain detailed regulatory affairs and compliance programs and/or issues.
  • Tissue Services RA Manager may be filled with RA Associate II level position with demonstrated skill and experience required for position.

 

 

 

 

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed