Associate Program Director - Devices and Combination Products
Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 8, 2021
The Associate Regulatory Program Director position is an
individual contributor role within the Technical Regulatory (PTR)
organization and will be responsible for developing and executing
regulatory strategies and initiatives for combination products and
devices with a strong focus on the Port Delivery System device
(PDS) platform. PDS is an innovative, implantable, refillable
drug-delivery device designed to provide continuous delivery of
drugs to the eye, with the potential for better treatment outcomes
for patients with various ocular disease. In this role, you will be
an integral member of the PTR devices and combination products
group. This position can be based in South San Francisco, CA;
Basel, Switzerland; or remote.
Help develop the Port Delivery System devices regulatory
strategy, with focus on device registration and life cycle
management to support the business needs, in close collaboration
with the technical development project team
Participate in creation and lifecycle management of device
sections of IND/CTA and BLA/NDA/MAA, and technical files including
responses to questions from health authorities. Responsible for
timely compilation of necessary CMC documents to support technical
contents of regulatory submissions.
Provide input to cross-functional teams including clinical,
safety science, and commercial to enhance organizational knowledge
and capability related to combination products and devices.
Represent PDS platform in internal combination products and
device specific initiatives and working groups to enhance and
enable Roche capability related to global device registration.
Build strong collaborations and relationships with internal
stakeholders to ensure successful execution of regulatory
- Stay abreast of changing regulatory requirements. Analyze
regulations, rules, or guidance documents and communicate potential
impact to internal stakeholders.
Scientific degree preferred, an advanced degree desired.
A minimum of 10 years of industry experience in regulatory
and/or quality related field in the medical device industry,
including applicable experience with implantable medical devices.
Applicants with a minimum of 5 years of experience in regulatory
will be considered for Regulatory Program Manager.
Knowledge of ISO guidance documents and health authority
regulations/standards relevant to combination products or devices,
specifically 21 CFR part 4, 21 CFR part 820, 21 CFR part 803, 21
CFR part 801, 21 CFR part 830; ISO 13485, ISO 14971, and EU Medical
Experience in global device registration, including CE-mark,
510(k), PMA, IDE, CTA regulatory approval processes are
Excellent communication, collaboration, and interpersonal
Dynamic personality, ability to think outside the box and take
Ability to think "big picture" and focus on details.
Curiosity and an ability to learn and deal with ambiguity within
Effective problem solving and strong organizational skills,
including ability to prioritize tasks.
Drive for continuous improvements and operate with lean
- Flexible work arrangements and remote work from a US-based
location outside of commuting distance from a Genentech location,
will be considered.
Keywords: Hoffmann-La Roche Ltd, South San Francisco , Associate Program Director - Devices and Combination Products, Other , South San Francisco, California
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