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Title:  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:  Manager, Regulatory

Affairs

 

 

PURPOSE OF POSITION:  The Regulatory Specialist supports regulatory activities for Enable Injections Customer projects. Such professional will assist in the preparation and coordination of regulatory documentation or submissions, perform literature-based research, and maintain and compile regulatory documentation

 

 

QUALIFICATIONS

 

 

Required:

  • Excellent analytical abilities; strong communication skills; and an ability to interface with regulatory authorities, suppliers and customers, as needed.
  • Effective attention to detail in order to successfully oversee regulatory initiatives.
  • 0-1 year Regulatory experience (medical device, pharmaceutical, and/or combination products).
  • Bachelor's degree in biology, chemistry, or a related field

Preferred:

  • A strong knowledge of domestic and international regulations is beneficial.
  • Master’s or higher in a scientific discipline

Skills & Competencies:

  • Strong leadership and interpersonal skills.
  • Experienced in technical/scientific writing
  • Experienced 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 constantly operate a computer and other office equipment, such as printer, telephone, etc.

RESPONSIBILITIES:

  • Support cross-functional team deliverables and activities, including regulatory submissions. Assist the project Regulatory Lead to execute deliverables.
  • Perform literature-based research to support regulatory submissions and post-market activities
  • Prepare responses to Enable Injections Customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires;
  • Write technical summaries
  • 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
  • Writing comprehensible, user-friendly, clear finished product artwork and labels;
  • Development knowledge of Quality System (ISO 13485, 21 CFR 820, 21 CFR Part 4) requirements and domestic and international regulatory framework
  • Develop or track quality metrics
  • Supporting 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