Regulatory Affairs Specialist 3

MillenniumSoft, Inc

• $90K — $120K *
Irvine, CA 92620In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • 5-7 years of hands-on experience in Regulatory Affairs
  • Experience with Class II and/or Class III medical devices
  • Familiarity with global regulatory submissions and compliance
  • Bachelor's Degree in a scientific discipline (Biology, Microbiology, Chemistry, or related)
  • Preferred coursework or training in regulatory affairs

Responsibilities

  • Support US and EU regulatory submissions while safeguarding proprietary information
  • Track regulatory timelines and document key milestones
  • Assess regulatory impacts and aid in developing regulatory strategies
  • Review and approve change requests and notifications
  • Provide guidance on new/renewal registrations and product changes
  • Collaborate across functions with internal teams
  • Perform additional duties as directed by leadership

Benefits

  • Opportunity for professional development and training in regulatory affairs
  • Engagement in cross-functional team collaboration
  • Exposure to both US and EU regulatory environments
  • Involvement with medical devices at advanced regulatory levels
  • Potential for leadership opportunities within the regulatory team
Full Job Description
Roles & Responsibilities

  • Support US and EU regulatory submissions, ensuring protection of proprietary information
  • Track regulatory timelines and document milestone achievements
  • Assess regulatory impact and contribute to regulatory strategy development
  • Review, collaborate on, and approve change requests and change notifications
  • Provide guidance to regulatory teams on:
    • New and renewal registrations
    • Product and process changes
    • Labeling content and compliance
  • Collaborate cross-functionally with internal teams
  • Perform additional duties as assigned by leadership


Experience Required

  • 5-7 years of hands-on experience in Regulatory Affairs
  • Experience supporting medical devices (Class II and/or Class III)
  • Exposure to global regulatory submissions and compliance requirements


Skills & Certifications

  • Strong knowledge of US and EU regulatory frameworks
  • Understanding of global regulations for new products and product changes
  • Excellent written and verbal communication skills
  • Strong analytical, problem-solving, and critical-thinking abilities
  • High attention to detail and documentation accuracy
  • Ability to manage multiple priorities in a fast-paced environment
  • Proficient in Microsoft Word, Excel, and PowerPoint
  • Strong interpersonal and stakeholder management skills
  • Team-oriented with cross-functional collaboration experience


Eligibilities & qualifications

  • Bachelor's Degree or equivalent in a scientific discipline

    (Biology, Microbiology, Chemistry, or related field)
  • Relevant regulatory coursework, seminars, or formal training preferred
* Ladders Estimates

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