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Associate Program Director - Devices and Combination Products

Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 8, 2021

Job Description:

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.

Primary responsibilities:

  • 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 submissions.

  • Stay abreast of changing regulatory requirements. Analyze regulations, rules, or guidance documents and communicate potential impact to internal stakeholders.

Qualifications:

  • 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 Device Regulation.

  • Experience in global device registration, including CE-mark, 510(k), PMA, IDE, CTA regulatory approval processes are desirable.

  • Excellent communication, collaboration, and interpersonal skills.

  • Dynamic personality, ability to think outside the box and take smart risks.

  • Ability to think "big picture" and focus on details.

  • Curiosity and an ability to learn and deal with ambiguity within the organization.

  • Effective problem solving and strong organizational skills, including ability to prioritize tasks.

  • Drive for continuous improvements and operate with lean mindset.

  • Flexible work arrangements and remote work from a US-based location outside of commuting distance from a Genentech location, will be considered.
  • LI-KD1

Keywords: Hoffmann-La Roche Ltd, South San Francisco , Associate Program Director - Devices and Combination Products, Other , South San Francisco, California

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