Regulatory Affairs Specialist

1 week ago

Raleigh, NC, United States Pacer Group Full time
Job Title: Regulatory Affairs Specialist

Job Location: Raleigh, NC 27615

Job Duration: 7 months

Job Summary:
  • The Regulatory Affairs Specialist will be responsible for supporting regulatory activities for existing US FDA class III medical devices.
  • This role provides support to currently-marketed products, involves evaluating proposed product and process changes, assessing documentation and providing guidance to ensure regulatory compliance.
  • The Regulatory Affairs Specialist will work collaboratively with internal stakeholders.
  • From preparing and authoring regulatory submissions to providing critical input on cross-functional project teams and developing regulatory strategy, this role is an excellent opportunity for the right regulatory professional.
  • The ideal candidate will be curious, analytical and a self-starter, unafraid to ask questions or over-communicate.
Job Responsibilities:
  • Regulatory strategy • Support strategy development for US FDA class III medical devices and combination products in the post-market lifecycle.
  • Regulatory assessments • Review product and process changes and conduct regulatory assessments, ensuring the appropriate regulatory strategies are communicated to internal stakeholders.
  • Conduct risk assessments and provide recommendations to mitigate regulatory risks.
  • Regulatory submissions • Prepare, review, and submit regulatory submissions, including PMA supplements and reports for class III medical devices.
  • Regulatory compliance • Maintain documentation and databases in accordance with internal procedures and applicable regulations, standards, and guidelines (e.g. FDA, ISO, USP).
  • Regulatory interface and communication • Respond to regulatory agencies and coordinate responses with subject matter experts.
  • Ensure internal stakeholders are apprised of inquiries from health authorities during the submission approval process according to departmental communication cascades.
  • Cross-functional collaboration • Collaborate with cross-functional teams (e.g., Quality, Operations, Marketing, Supply Chain) to ensure regulatory requirements are met in throughout the product lifecycle.
Technical & Functional Skills:
  • Knowledge of medical device regulations and governing laws such as 21 CFR 814, 21 CFR 814, 21 CFR 820.
  • Strong analytical, investigative, and organizational skills. Demonstrate curiosity preferred.
  • Ability to work under pressure, prioritize, and handle multiple tasks.
  • Self-starter with results-oriented mindset.
  • Excellent written and verbal communications skills.
Minimum Qualifications:
  • University degree; scientific discipline preferred, or the required years of direct experience.
  • 4+ years' experience in medical device industry
  • 2+ years' direct experience in medical device regulatory affairs, preferably with FDA class III devices.
  • Knowledge of Quality Management System standards, including ISO 13485 and ISO 9001.
  • Proficiency in MS Office (Excel, PowerPoint and Word)
Preferred Qualifications:
  • Prior experience with PMA Class III devices
  • Strong communication skills
  • Ability to quickly adapt to changes in fast-paced environment
Physical Requirements:
  • This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.
  • Document management • Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices.
Essential Skills - Lead Self:
  • Attention to Detail
  • Analytical Skills
  • Time Management
  • Digital Acumen
  • Problem Solving
  • Emotional Intelligence
  • Resiliency
  • Communication Leadership
  • Collaboration
  • Project Management
  • Motivate & Influence
Essential Skills - Lead Others:
  • Leadership
  • Collaboration
  • Project Management
  • Motivate & Influence

  • Regulatory Affairs Specialist

    6 days ago

    Raleigh, NC, United States AA2IT Full time

    HCR0003126 Title - Regulatory Affairs Specialist Location - Remote Pay Rate - $45-80/HR Six month Contract (with intent to extend another six months) EU and US Ad/Promo Consultant (part-time - 20 hours/week) Remote (Eastern time zone or Frankfurt time) Standard business hours local to the contractor, Tuesday-Thursday (flexible on this) The Advertising and...

  • Regulatory Affairs Specialist

    1 week ago

    Raleigh, NC, United States AA2IT Full time

    HCR0003126 Title - Regulatory Affairs Specialist Location - Remote Pay Rate - $45-80/HR Six month Contract (with intent to extend another six months) EU and US Ad/Promo Consultant (part-time - 20 hours/week) Remote (Eastern time zone or Frankfurt time) Standard business hours local to the contractor, Tuesday-Thursday (flexible on this) The Advertising and...

  • Regulatory Affairs Specialist

    1 week ago

    Raleigh, NC, United States AA2IT Full time

    HCR0003126 Title - Regulatory Affairs Specialist Location - Remote Pay Rate - $45-80/HR Six month Contract (with intent to extend another six months) EU and US Ad/Promo Consultant (part-time - 20 hours/week) Remote (Eastern time zone or Frankfurt time) Standard business hours local to the contractor, Tuesday-Thursday (flexible on this) The Advertising and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Raleigh, NC, United States AA2IT Full time

    HCR0003126 Title - Regulatory Affairs Specialist Location - Remote Pay Rate - $45-80/HR Six month Contract (with intent to extend another six months) EU and US Ad/Promo Consultant (part-time - 20 hours/week) Remote (Eastern time zone or Frankfurt time) Standard business hours local to the contractor, Tuesday-Thursday (flexible on this) The Advertising and...

  • PMA Contractor- Regulatory affairs

    1 week ago

    Raleigh, NC, United States Spectraforce Technologies Full time

    PMA Contractor- Regulatory affairs Remote role 12 monthsShift/Time Zone: 8-5 day shift (M-F), flexibility in schedule if neededCandidate can be remote in the US but West Coast is preferred for PST time zone.Job Description: * Regulatory affairs role (for this project, looking for someone with at least 5 years direct relevant PMA experience) * Hands-on...

  • PMA Contractor- Regulatory affairs

    1 week ago

    Raleigh, NC, United States Spectraforce Technologies Full time

    PMA Contractor- Regulatory affairs Remote role 12 monthsShift/Time Zone: 8-5 day shift (M-F), flexibility in schedule if neededCandidate can be remote in the US but West Coast is preferred for PST time zone.Job Description: * Regulatory affairs role (for this project, looking for someone with at least 5 years direct relevant PMA experience) * Hands-on...

  • PMA Contractor- Regulatory affairs

    4 days ago

    Raleigh, NC, United States Spectraforce Technologies Full time

    PMA Contractor- Regulatory affairs Remote role 12 monthsShift/Time Zone: 8-5 day shift (M-F), flexibility in schedule if neededCandidate can be remote in the US but West Coast is preferred for PST time zone.Job Description: * Regulatory affairs role (for this project, looking for someone with at least 5 years direct relevant PMA experience) * Hands-on...

  • PMA Contractor- Regulatory affairs

    4 days ago

    Raleigh, NC, United States Spectraforce Technologies Full time

    PMA Contractor- Regulatory affairs Remote role 12 monthsShift/Time Zone: 8-5 day shift (M-F), flexibility in schedule if neededCandidate can be remote in the US but West Coast is preferred for PST time zone.Job Description: * Regulatory affairs role (for this project, looking for someone with at least 5 years direct relevant PMA experience) * Hands-on...

  • Senior Manager, Regulatory Affairs

    1 week ago

    Raleigh, NC, United States ICON Clinical Research Full time

    Senior Manager, Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Sr Manager, Regulatory Affairs - IVD Location: US Remote,...

  • Senior Manager, Regulatory Affairs

    2 weeks ago

    Raleigh, NC, United States ICON Clinical Research Full time

    Senior Manager, Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Sr Manager, Regulatory Affairs - IVD Location: US Remote,...