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Director, Regulatory Affairs

Enable Injections

Enable Injections

Legal, Sales & Business Development
Posted on Thursday, August 31, 2023

 

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.

 

QUALIFICATIONS

 

Required:

 

  • Excellent analytical abilities, strong communication skills in order to collaborate with colleagues and interface with suppliers and customers as needed.
  • Effective attention to detail in order to successfully oversee regulatory initiatives.
  • A minimum of 10 years of device design and development experience.
  • Minimum of 10 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
  • Bachelor's degree in relevant field

 

 

Preferred:

 

  • A strong knowledge of domestic and international regulations.
  • Master’s in business or scientific discipline.

 

Skills & Competencies:

 

  • Excellent analytical abilities, strong communication skills, and effective attention to detail
  • Strong leadership and interpersonal skills.
  • Ability to develop personnel through mentoring and coaching, both formally and informally, and most importantly by example.
  • Versed at developing metrics and implementing actions that make improvements in those metrics.
  • Experience in developing and conducting presentations with Power Point

 

 

RESPONSIBILITIES:

 

  • Leads the Regulatory department and acts as the face of Enable in interactions with partners and regulatory authorities.
  • Directs the workload and oversees the output of a team of regulatory professionals.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Prepare or direct the preparation of master files and technical files as necessary to obtain and sustain product approval.
  • Ensure compliance with regulations.
  • Outlining requirements for labelling, storage, and packaging.
  • Writing comprehensible, user-friendly, clear finished product artwork and labels.
  • Oversees post-market work to ensure products remain in compliance once on the market.

 

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.