This job offer is not available in your country.

Regulatory Scientist

DEEP MeasuresUnited Kingdom

30+ days ago

Job type

Full-time

Job description

Join to apply for the Regulatory Scientist role at DEEP Measures

At DEEP Measures, excellence in regulatory science and thinking has been a key component of our success. In this role, you will collaborate with internal and external stakeholders, including regulators and thought leaders, to lead projects with Health Authorities. You will coordinate the Global Advocacy Network forum with policy experts from our customers and provide advice on regulatory strategy and interactions, focusing on digital measures of health and measurement technologies. This role is ideal for a seasoned regulatory expert interested in advancing this exciting field. Given the rapid developments in this area, curiosity about regulatory science and digital endpoints is essential. You will work with the DEEP model for structured evidence, supporting the creation of measurement definitions, target solution profiles, and digital measurement solutions from a regulatory perspective. You will also lead regulatory pilots with various agencies on both the pharmaceutical and medical device sides

Key Duties and Responsibilities

The followingduties and responsibilities are crucial for a Regulatory Scientist specializing in digital endpoints to ensure successful regulatory approval and compliance :

Conduct research and stay updated on regulatory requirements related to digital endpoints in the pharmaceutical and healthcare industries.
In partnership with customers, develop regulatory strategies for digital endpoints, ensuring compliance with relevant guidelines and standards.
Prepare and submit regulatory submissions to health authorities for digital endpoints qualifications and acceptance, such as Qualification of Novel Methodologies, Scientific Advice, Innovation Task Force in Europe, and IND interactions, DDT qualification procedures in the US.
Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product development lifecycle.
Provide regulatory guidance and support to customers and internal teams on digital endpoint-related matters.
Participate in meetings with regulatory agencies to discuss digital endpoint submissions and address any questions or concerns.
Lead projects with regulatory agencies (e.g. pilots)
Coordinate Global Advocacy Network forum with thought leaders from industry and coordinate project delivery
Review and assess data generated from digital endpoints to ensure quality, integrity, and compliance with regulatory requirements.
Contribute to the development of regulatory policies and procedures specific to digital endpoints and partner with industry and regulators to move the ecosystem forward.
Monitor and track changes in regulations and guidelines related to digital endpoints, and communicate updates to relevant stakeholders.

In addition youwill be responsible for :

Ensuring appropriate classification of the information in the DEEP Catalog based on confidentiality and copyright, and assigning appropriate level of access.

Creating, maintaining and adhering to guidelines and standards for populating content in the DEEP Catalog.

Managing multiple projects simultaneously, coordinating timelines, priorities, and resources to ensure timely completion of deliverables.

Communicating directly with clients and external stakeholders to understand project requirements, provide updates, and address feedback or questions.

Other responsibilities as assigned.

Qualifications

Bachelor or Master’s degree in life sciences, pharmacy, digital health, medical technology or related field.

Required Experience

Advanced knowledge of the science of digital health and medical technology

Advanced knowledge of the regulatory science of digital endpoints, including regulatory procedures and strategies

Knowledge in leading regulatory procedures and working with regulators

A self-starter that can also collaborate well with a remote team

A high degree of curiosity and eagerness for learning something new every day

An ability to work and adapt in a fast-moving start-up environment

An ability to analyze and synthesize complex information

Excellent writing and communication skills, including presentation skills

Experience in regulatory policy and working with external key thought leaders

Research experience in life sciences

What we offer

We are a young and growing start-up and our team moves at a fast pace. You will have opportunities to work with all the company members and partners, learn different aspects of a business and grow in new areas. We offer a competitive compensation package.

DEEP Measures is an equal opportunity employer

We are committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or disability status.

If you are interested in working with us, please submit your resume and cover letter via our website form.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Legal

Industries

Hospitals and Health Care

Referrals increase your chances of interviewing at DEEP Measures by 2x

Get notified about new Regulatory Scientist jobs in United Kingdom .

London, England, United Kingdom 2 weeks ago

Senior Regulatory Affairs Specialist - EU- Home Based

Senior Regulatory Affairs Specialist - EU- Remote

Senior Regulatory Affairs Specialist - Johnson & Johnson MedTech | Cardiovascular

Wokingham, England, United Kingdom 1 week ago

Ellesmere Port, England, United Kingdom 2 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr

Create a job alert for this search

Scientist • United Kingdom