Global Digital Regulatory Lead

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Job description

Job Summary

Provides strategic regulatory expertise and leadership for global and regional health authority

interactions and submissions, and applies advanced theories and principles to develop new

practices and strategic approaches. With a focus on digital medical devices and therapeutics,

engages with digital alliances/forums to shape and develop regulatory and reimbursement

landscape and ensure Otsuka's voice is heard with upcoming policy changes. Identifies

opportunities to enhance a develop all Otsuka digital assets including novel digital therapeutics

and SaMD products.

Job Description

The Global Digital Regulatory Lead is in charge of leading efforts for advancing digital therapeutics

within Otsuka and being at the forefront within the regulatory landscape. This individual will be required

to meet with policymakers and engage in productive exchange progressing the advancement of these

novel products. Will represent Otsuka on all regulatory matters related to Software as a Medical Device

(SaMD), including meetings with executive leadership, meetings with FDA and other regulators and

policymakers, representation within digital alliance associations, and working with our development

partners. As an expert in the field, applies strategy and principles to support the development of new

concepts and practices.

This role will contribute to the regulatory strategy for digital products and be at the forefront of the digital

landscape providing Otsuka with a cutting edge mindset that will progress digital therapeutics. This role

must be able to combine scientific, regulatory and business knowledge to assure that our products are

developed and distributed according to all applicable regulations for SaMD in alignment with the

company's strategic goals. This individual should have a very firm understanding of medical device

regulations and a creative approach to bringing safe and efficacious products to patients efficiently and

in a patient centric manner. This role will have high exposure across all functional areas within Otsuka

and externally with multiple key audiences, such as scientific and clinical advisors, regulators, and

investors, and will advocate for the continuous advancement of the science and regulation of digital

therapeutics.

Responsibilities

· Meet with peer groups as well as policy makers to ensure new innovative products are made

available to patients in an efficient manner

Develop and implement a comprehensive set of policies and processes that support the rapidly changing SaMD space. · Establish policies/standards for novel digital therapeutic products. · Participates with other senior leaders to establish strategic plans and objectives.

· Effectively communicates and aligns with all executive stakeholders and ensures senior management has an up-to-date understanding of the current requirements and anticipates the future landscape and evolution of the digital therapeutics field.

· Provide risk and compliance assessments concerning the company's products.

· Drive regulatory evaluation and guide on due diligence activities and provide regulatory assessment to management.

· Perform global regulatory intelligence including monitoring regulatory updates, workshops, discussions, and other news sources. Advance internal awareness of current and upcoming regulations, requirements and expectations, and identify training and educational needs for the organization.

· Serve as the internal go-to subject matter expert on regulatory matters concerning software as a medical device. This includes providing regulatory advice and oversight to other functional areas.

Qualifications:

• Bachelor's Degree required, preferred in life sciences, health care, or related discipline.

• 10+ years of experience in medical device regulatory affairs.

• A comprehensive understanding and experience with implementation of medical device

regulations, including all relevant sections of Title 21 of the US Code of Federal Regulations and the

European Union Medical Device Directive (MDD) and/or Regulation (MDR).

• Familiarity with the legal basis of FDA's regulatory authority, including the US Food, Drug &

Cosmetic Act and all related amendments.

• Experience with regulatory matters concerning Software as a Medical Device (SaMD) and/or

Software in a Medical Device (SiMD).

• Record of successful medical device filings, including 510(k), De Novo, PMA and/or CE Mark.

• Familiarity with drug regulations and regulatory pathways, including drug-device combination

products.

• Experience with Quality Management Systems and applicable regulatory compliance

requirements.

• Expertise in GxP requirements for clinical, manufacturing and other relevant practices.

• Understanding of the principles and requirements of promotion, advertising and labeling.

• Prior experience with international medical device regulatory requirements and marketing

authorization.

• Excellent writing and oral communication skills.

• Ability to form and maintain working professional relationships with external stakeholders,

regulatory authorities and scientific and clinical advisors.

• Prior experience and demonstrated ability to work in diverse therapeutic areas.

• Strong leadership skills with ability to set a vision, lead change, grow a team and mentor others

Preferred Qualifications:

• Certification in regulatory affairs (such as RAC from the Regulatory Affairs Professionals

Society)

• Prior leadership or management experience in the regulatory affairs department of a medical

device company that develops class II products

• Experience with digital therapeutics

• Experience with artificial intelligence and machine learning

• Experience with combination drug-device products,

• MS or PhD in a technical area

Come discover more about Otsuka and our benefit offerings; .

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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