Sr. Regulatory Affairs Manager – Medical Device

Uptake Medical Technology is seeking a full-time Sr. Regulatory Affairs Manager. This is a special opportunity to join an expertly managed, privately held, commercial stage interventional pulmonology medical device company.

Responsible for global regulatory submissions, global product registrations, general regulatory compliance support.

Essential Duties and Responsibilities:

  • Prepare and support regulatory submissions (Design Dossiers, Technical Files, IDE, Notified Body Submissions, PMAs, 510(k)s, revisions/supplements, etc.) in a timely manner, meeting current regulations and guidance document requirements
  • Facilitate site registrations in targeted countries and ensure compliance to applicable regulations.
  • Maintain FDA registration and export documentation as needed.
  • Review labeling (including IFU), publications and promotional material to ensure claims related to medical device safety and efficacy can be substantiated
  • · Communicate recommendations for regulatory strategies including regulatory pathways, compliance test requirements, substantial change notifications to notified body, and responses to queries from FDA, Notified Body, TGA and other targeted commercial countries.
  • · Participate in risk management reviews and assessment of complaints
  • · Prepare and submit annual reports
  • · Support review of clinical documentation including protocols and reports.
  • · Review plans, FMEAs, verification and validation protocols and reports, for internal consistency, standards application and effects on submissions.

Minimum Education and/or Experience:

  • Bachelor’s degree required. Course program(s) or advanced training in Regulatory Affairs preferred.
  • Minimum 5 years experience in the medical device industry with 3 years in regulatory affairs role supporting submissions.

Requirements:

  • Previous FDA and OUS submission experience.
  • Ability to manage multiple priorities in a high-pressure environment.
  • Working knowledge of current revisions of:
    • EN ISO 13485 Medical Devices – Quality Management System
    • MDD 93/42/EEC: Medical Devices Directive
    • Title 21 CFR Part 820: FDA Quality System Regulation
    • EN ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
  • Must have excellent verbal and interpersonal skills
  • Ability to contribute and collaborate in a creative, fast-paced and team-oriented environment.
  • Excellent problem-solving skills.
  • Ability to create and execute effective plans to address issues/goals.
  • Some travel required, domestic and international.

To Apply: please submit resume in a word doc or PDF to kjordan@uptakemedical.com


Sr. Manager, Quality – Medical Device

Uptake Medical Technology is seeking a full-time Sr. Manager, Quality. This is a special opportunity to join an expertly managed, privately held, commercial stage interventional pulmonology medical device company.

The Sr. Manager, Quality will have primary responsibility for the implementation and management of the company’s Quality System to include: ensure compliant and effective document control system, analyze and prepare recommendations for status and improvement regarding the Quality System to senior management on a regular basis and serve as a management representative.

Essential Duties and Responsibilities:

  • Support the Uptake Medical Quality System that complies with ISO 13485, MDD, ISO 14971, and CFR Part 820.
  • Assure that quality systems are integrated with appropriate collaboration with affected areas.
  • Analyze and report on Quality System effectiveness at management review meetings.
  • Direct and ensure compliance to Supplier Quality System
  • Serve as Management Representative at Management Reviews and track action items.
  • Participate in risk management reviews
  • Manage and ensure compliance to the Internal Audit program
  • Direct and ensure compliance with CE mark activities as they relate to site certification.
  • Interface with notified body for activities related to CE mark approval and ISO 13485 certification.
  • Assist with complaint handling program
  • Manage and support compliance to the Document Control and employee training system programs
  • Manage and support compliance to Supplier Quality System
  • Ensure all documentation is in compliance with applicable FDA and ISO standards/regulations and internal procedures.
  • Conduct or facilitate training on all areas of the Quality System.

Minimum Education and/or Experience:

  • Bachelor’s degree required.
  • 4+ years of experience in a medical device setting or equivalent
  • Knowledge of, and ability to ensure compliance to, FDA, MDD and ISO standards related to the Quality System.

Requirements:

  • Must have excellent verbal and interpersonal skills.
  • Ability to work successfully with a variety of internal and external sources
  • Ability to manage multiple priorities.
  • Excellent computer skills, Microsoft project experience preferred.
  • Working knowledge of:
    • ISO 13485:2016: Medical Devices – Quality Management System
    • MDD 93/42/EEC: Medical Devices Directive
    • Title 21 CFR Part 820: FDA Quality System Regulation
    • ISO 14971:2012: Medical Devices – Application of Risk Management to Medical Devices
  • Exceptional problem-solving skills.
  • Ability to create and execute effective plans to address issues/goals.
  • Some travel required, domestic and international.

To Apply: please submit resume in a word doc or PDF to kjordan@uptakemedical.com