Talent.com
Regulatory Affairs Manager

Regulatory Affairs Manager

VirtualVocationsDurham, North Carolina, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

A company is looking for a Regulatory Affairs Manager.

Key Responsibilities

Maintain the Quality Management System (QMS) and ensure compliance with regulatory standards

Collaborate with cross-functional teams to design workflows that enhance quality without hindering product velocity

Lead documentation efforts and support product teams through process changes and onboarding

Required Qualifications

3+ years of experience in quality, compliance, regulatory, or technical program management

Experience with QMS systems and FDA documentation workflows

Proven ability to implement structured processes in fast-paced environments

Basic technical fluency in machine learning, product development, and system design

Experience with ISO 13485 or FDA SaMD regulations is a plus

serp_jobs.job_alerts.create_a_job

Regulatory Manager • Durham, North Carolina, United States

Job_description.internal_linking.related_jobs
  • serp_jobs.job_card.promoted
Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

VirtualVocationsDurham, North Carolina, United States
serp_jobs.job_card.full_time
A company is looking for a Senior Manager, Global Regulatory Affairs Labeling.Key Responsibilities Drives end-to-end labeling process and strategy for product lifecycle management and implementat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Affairs Manager

Regulatory Affairs Manager

Katalyst Healthcares & Life SciencesRaleigh, NC, US
serp_jobs.job_card.full_time
Responsibilities : In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Regulatory Affairs Manager, CMC & Labeling (Relocation assistance available)

Regulatory Affairs Manager, CMC & Labeling (Relocation assistance available)

Iviva MedicalDurham, NC, US
serp_jobs.job_card.full_time
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation.Our public benefit purpose is to provide a brighter future for patients through t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
  • serp_jobs.job_card.new
Regulatory Affairs Specialist Medical device Experience (Raleigh)

Regulatory Affairs Specialist Medical device Experience (Raleigh)

AccuroRaleigh, NC, US
serp_jobs.job_card.part_time +1
Job Title : Regulatory Affairs Specialist Medical device Experience.The Regulatory Affairs Specialist will be responsible for supporting regulatory activities for existing US FDA class III medical d...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_hour
  • serp_jobs.job_card.promoted
  • serp_jobs.job_card.new
Regulatory Affairs Specialist II (Durham)

Regulatory Affairs Specialist II (Durham)

Katalyst HealthCares & Life SciencesDurham, NC, US
serp_jobs.job_card.part_time
Responsibilities : As an individual contributor, this position performs specialized level work assignments and / or analyses, evaluation, preparation, and submission of documentation for regulatory ap...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_hour
  • serp_jobs.job_card.promoted
Senior Regulatory Associate

Senior Regulatory Associate

Invenia GroupRaleigh, NC, US
serp_jobs.job_card.full_time
Invenia Group has partnered with a fast-growing BioPharma company, looking to hire a Senior Associate, Regulatory to play a critical role in ensuring compliance with global regulatory requirements ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Assistant Director, Accreditation and Regulatory Affairs

Assistant Director, Accreditation and Regulatory Affairs

Duke UniversityDurham, NC, US
serp_jobs.job_card.full_time
Assistant Director, Accreditation and Regulatory Affairs.The Assistant Director, Accreditation and Regulatory is responsible for leading system accreditation and regulatory programs at Duke Univers...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Submissions Manager

Regulatory Submissions Manager

VirtualVocationsRaleigh, North Carolina, United States
serp_jobs.job_card.full_time
A company is looking for a Regulatory Submissions Manager to support high-priority regulatory activities in the biopharma sector. Key Responsibilities Lead and coordinate the preparation, formatti...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
  • serp_jobs.job_card.promoted
Director of Regulatory Affairs

Director of Regulatory Affairs

VirtualVocationsDurham, North Carolina, United States
serp_jobs.job_card.full_time
A company is looking for a Director of Regulatory Affairs, Remote.Key Responsibilities Analyze and communicate newly enacted federal and state laws and regulations affecting various business sect...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Sr Regulatory Affairs Specialist

Sr Regulatory Affairs Specialist

TeleflexRaleigh, NC, US
serp_jobs.job_card.full_time
Sr Regulatory Affairs Specialist.Teleflex is investing in our capability to drive material cost improvement opportunities as part of a strategic corporate approach to reversing recent trends in cos...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
  • serp_jobs.job_card.new
Senior Regulatory Associate (Raleigh)

Senior Regulatory Associate (Raleigh)

Invenia GroupRaleigh, NC, US
serp_jobs.job_card.part_time
Invenia Group has partnered with a fast-growing BioPharma company, looking to hire a Senior Associate, Regulatory to play a critical role in ensuring compliance with global regulatory requirements ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_hour
  • serp_jobs.job_card.promoted
Regulatory Affairs Manager

Regulatory Affairs Manager

VirtualVocationsRaleigh, North Carolina, United States
serp_jobs.job_card.full_time
A company is looking for a Regulatory Affairs Manager.Key Responsibilities Maintain the Quality Management System (QMS) and ensure compliance with regulatory standards Collaborate with cross-fun...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Assistant Director, Accreditation and Regulatory Affairs

Assistant Director, Accreditation and Regulatory Affairs

Duke Clinical Research InstituteDurham, NC, United States
serp_jobs.job_card.full_time
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and disc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
  • serp_jobs.job_card.new
Senior Staff Regulatory Affairs Associate # (Durham)

Senior Staff Regulatory Affairs Associate # (Durham)

GRAIL, Inc.Durham, NC, US
serp_jobs.job_card.full_time +1
Senior Staff Regulatory Affairs Associate # 4333.GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. We are using the power of next-generation sequencing (N...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_hour
  • serp_jobs.job_card.promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Katalyst Healthcares & Life SciencesDurham, NC, US
serp_jobs.job_card.full_time
Responsibilities : Perform assessment of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to assess acceptability and identify potential risks.Assesse...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
  • serp_jobs.job_card.new
Sr Regulatory Affairs Strategy Specialist (Durham)

Sr Regulatory Affairs Strategy Specialist (Durham)

Becton DickinsonDurham, NC, US
serp_jobs.job_card.part_time
Senior Regulatory Affairs Strategy Specialist.BD is one of the largest global medical technology companies in the world.Advancing the world of health is our Purpose, and it's no small feat.It takes...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_hour
  • serp_jobs.job_card.promoted
Sr Regulatory Affairs Strategy Specialist

Sr Regulatory Affairs Strategy Specialist

Becton DickinsonDurham, NC, US
serp_jobs.job_card.full_time
Senior Regulatory Affairs Strategy Specialist.BD is one of the largest global medical technology companies in the world.Advancing the world of health is our Purpose, and it's no small feat.It takes...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

TeleflexRaleigh, NC, US
serp_jobs.job_card.full_time
The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Director of Regulatory Implementation

Director of Regulatory Implementation

VirtualVocationsDurham, North Carolina, United States
serp_jobs.job_card.full_time
A company is looking for a Director, Regulatory Implementation.Key Responsibilities Directs the regulatory implementation program and manages a portfolio of 50+ implementation projects Facilitat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
  • serp_jobs.job_card.promoted
Senior Staff Regulatory Affairs Associate # 4333

Senior Staff Regulatory Affairs Associate # 4333

GrailDurham, NC, US
serp_jobs.job_card.full_time
Senior Staff Regulatory Affairs Associate # 4333.GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. We are using the power of next-generation sequencing (N...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30