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Regulatory affairs • portland or

Last updated: 20 hours ago
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Senior Manager, Regulatory Affairs - IVD

Senior Manager, Regulatory Affairs - IVD

ICONPortland, OR, US
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...Show moreLast updated: 20 hours ago
Healthcare Regulatory Associate

Healthcare Regulatory Associate

5 LegalPortland, OR, US
Full-time
Top 50 AmLaw firm seeks an associate to join its Healthcare Practice Group in their Portland office.Qualified candidates must have 3 years of experience or a demonstrated interest in health law in ...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Affairs Intern

Regulatory Affairs Intern

RegASKPortland, OR, US
Full-time
RegASK is an AI-driven solution enabling end-to-end intelligent regulatory workflow orchestration : automating regulatory intelligence with curated content and actionable insights, smart documentati...Show moreLast updated: 28 days ago
Public Affairs Specialists

Public Affairs Specialists

Jobs for HumanityPortland, OR, United States
Part-time
Jobs for Humanity is collaborating with Upwardly Global and with Unclassified to build an inclusive and just employment ecosystem. We support individuals coming from all walks of life.Job Title : Pub...Show moreLast updated: 2 days ago
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Director of Regulatory Affairs

Director of Regulatory Affairs

EnergyHubPortland, OR, US
Full-time
Director Of Regulatory Affairs.EnergyHub empowers utilities and their customers to create a clean, distributed energy future. Our mission is to integrate any customer or device to the grid to provid...Show moreLast updated: 28 days ago
Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

Reser's Fine FoodsBeaverton, OR , US
Full-time
We offer a competitive compensation and benefits package designed to help employees live a healthier life, build rewarding careers and save for the future. Reser’s offers choices whenever possible, ...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Precision for MedicinePortland, OR, US
Full-time
Regulatory Manager / Senior Regulatory Manager (Clinical Trials).Precision for Medicine is not your typical CRO.At Precision for Medicine we have brought together new technologies, expertise and op...Show moreLast updated: 13 days ago
  • Promoted
Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Precision MedicinePortland, OR, US
Full-time
Regulatory Manager / Senior Regulatory Manager (Clinical Trials).Precision for Medicine is not your typical CRO.At Precision for Medicine we have brought together new technologies, expertise and op...Show moreLast updated: 12 days ago
  • Promoted
Director, Medical Affairs

Director, Medical Affairs

Adaptive BiotechPortland, OR, US
Full-time
At Adaptive, we're Powering the Age of Immune Medicine.Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.As an Adapter, you'll h...Show moreLast updated: 29 days ago
Political Affairs Internship

Political Affairs Internship

The Borgen ProjectPortland, OR, United States
Part-time +1
Are you passionate about making a difference in the world? Look no further!.The Borgen Project is an international organization that works at the political level to improve living conditions for pe...Show moreLast updated: 2 days ago
Chief External Affairs Officer

Chief External Affairs Officer

YMCAPortland, OR, United States
Permanent
Lead philanthropy, marketing & community impact for the YMCA of Columbia-Willamette-advancing mission, visibility & $4M+ annual growth. This is an executive-level position designed for an experience...Show moreLast updated: 2 days ago
Vice President, Medical Affairs

Vice President, Medical Affairs

ConfidentialPortland, OR, United States
Full-time
Vice President, Medical Affairs.Industry-shaping mobile application empowering employees to improve heart health.The Company is in search of a VP, Medical Affairs to join their commercial team.The ...Show moreLast updated: 16 days ago
Regulatory Affairs Coordinator

Regulatory Affairs Coordinator

VirtualVocationsAloha, Oregon, United States
Full-time
A company is looking for a Regulatory Affairs Coordinator.Key Responsibilities Prepare and distribute notification letters based on accreditation determinations Maintain and track accredited and...Show moreLast updated: 30+ days ago
  • Promoted
Manager, Regulatory Affairs

Manager, Regulatory Affairs

KMR Search GroupPortland, OR, US
Full-time
This position supports both their individual and overall departmental goals regarding the number of filings to be submitted and approved yearly by planning, managing and assuring the quality of the...Show moreLast updated: 28 days ago
  • Promoted
Senior Regulatory Affairs Engineer

Senior Regulatory Affairs Engineer

Neko HealthPortland, OR, US
Full-time
Senior Regulatory Affairs Engineer.Join Neko Health as Senior Regulatory Affairs Engineer.Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs...Show moreLast updated: 29 days ago
  • Promoted
Staff Regulatory Engineer

Staff Regulatory Engineer

IT MotivesPortland, OR, US
Permanent
The Staff Regulatory Engineer is responsible for ensuring safety, performance, and regulatory requirements applicable to ensure our products are met for global markets. This position plans, schedule...Show moreLast updated: 9 days ago
  • Promoted
Senior Manager, Regulatory

Senior Manager, Regulatory

GrunsPortland, OR, US
Full-time
Grns is redefining how people experience health and performance through daily nutrition.We develop scientifically backed, high-quality dietary supplements designed to support multiple aspects of he...Show moreLast updated: 2 days ago
Chief External Affairs Officer

Chief External Affairs Officer

YMCA of Columbia WillamettePortland, OR, US
Permanent
This position is based in the Portland metropolitan area and operates in a hybrid work model, with 1–2 days per week expected in person at YMCA locations or offices.We’re an organizatio...Show moreLast updated: 25 days ago
Principal Professional, Regulatory Affairs – Labelling

Principal Professional, Regulatory Affairs – Labelling

DechraPortland, United States
Full-time
Principal Professional, Regulatory Affairs – Labelling.Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra!. Dechra is a growing, global specialist within the wo...Show moreLast updated: 30+ days ago
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Senior Manager, Regulatory Affairs - IVD

Senior Manager, Regulatory Affairs - IVD

ICONPortland, OR, US
20 hours ago
Job type
  • Full-time
Job description

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.

Location : US Remote, Portland, OR area preferred

We are currently seeking a Senior Manager, Regulatory Affairs to join our diverse and dynamic team. As a Senior Manager, Regulatory Affairs at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing :

  • Participate in provision of regulatory expertise in strategic drug development across multiple areas.
  • Take part in preparation of strategic development and submission plans.
  • Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally).
  • Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities.
  • Contribute to at least two of the following areas : interactions with regulatory agencies, early phase consulting, development planning (PDP / RDP / CDP), scientific / agency advice, orphan drugs / pediatric development, medical devices, regulatory intelligence, due diligence, strategic CT support / GCP compliance, biological / biotech / biosimilars, small company support (incl. SOPs development etc.).

Your profile :

  • A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical / CRO industry.
  • Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
  • Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail.
  • Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan / organize.
  • What ICON can offer you :

    Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

    In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

    Our benefits examples include :

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.