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Title:  Senior Specialist, Regulatory

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

SUPERVISOR’S TITLE:  Senior Manager, Regulatory Affairs

 

 

 

PURPOSE OF POSITION:

The Senior Regulatory Specialist acts as a regulatory expert between Enable Injections, Enable’s Customers and Regulatory Authorities and ensures that Enable Injections products are manufactured and distributed in compliance with appropriate legislations including, but not limited to: 21 CFR 820, ISO 13485, MDR 2017/745, etc.  Such professional will assist in defining submission strategies, prepare key regulatory documentation, and support meetings with Regulatory agencies and Notified Bodies.

QUALIFICATIONS

 

Required:

 

  • Excellent analytical abilities and strong communication skills in order to collaborate with colleagues and interface with suppliers, customers, and regulatory authorities as needed.
  • Effective attention to detail in order to successfully oversee regulatory initiatives.
  • A minimum of 3 years of Regulatory and/or Quality experience (medical device, pharmaceutical, and/or combination products)
  • Education: Bachelor's degree

 

 

Preferred:

 

  • Previous direct experience interacting with regulatory authorities
  • A strong knowledge of domestic and international regulations will be beneficial.
  • Education: Master’s or higher in a relevant scientific discipline (chemistry, biology, or related field)

 

 

Skills & Competencies:

 

  • Excellent analytical abilities, strong communication and writing skills, and effective attention to detail
  • Strong interpersonal skills.
  • Ability to work effectively cross-functionally and guide understanding of key Regulatory topics as an SME
  • Versed at developing metrics and implementing actions that make improvements in those metrics.
  • Experience in developing and conducting presentations with Power Point and other key Microsoft programs.

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to consistently operate a computer and other office equipment, such as printer, telephone, etc.

 

 

RESPONSIBILITIES:

 

  • Participate in Enable cross-functional teams as the Regulatory Affairs SME; provide regulatory strategy guidance, assess regulatory notification requirements of platform changes, etc.
  • Represent Enable as the primary Regulatory Lead and Point of Contact for partner programs as necessary;
  • Prepare responses to requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires;
  • Recommend and implement changes to company procedures in response to changes in regulations or standards;
  • Ensure compliance with regulations set by ISO 13485, 21 CFR 820, Medical Device Directive / Medication Device Regulations, and other key global requirements;
  • Prepare and maintain master files, technical files, or other regulatory submissions as necessary to obtain and sustain finished product approval in the US and global markets;
  • Prepare documentation needed to support investigational clinical studies conducted in the US (IND, IDE) or globally
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies;
  • Outline requirements for labelling, storage, and packaging;
  • Support post-market surveillance obligations in accordance with applicable US and global regulatory requirements (including MDR).

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  


Nearest Major Market: Cincinnati