Join to apply for the Regulatory Scientist role at DEEP Measures
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
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Hospitals and Health Care
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