Senior Regulatory Affairs Specialist - Clinical

MiniMed•Virtual, CA

1d•Remote

About The Position

This position sits in the regulatory organization of MiniMed and is charged with cross-functional collaboration to help build and advocate for innovative global clinical regulatory strategies for next generation diabetes devices, reimbursement, post-market surveillance activities, and expanding indications in the US, EU, and rest of world. These strategies will require a global mindset and critical thinking skills related to evolving global regulations. In this role, you will partner closely with clinical and medical affairs and work in a heavily matrixed environment consisting of functions from every aspect of the device lifecycle.

Requirements

Direct experience in the medical device industry, particularly with Class III/II medical devices for both FDA and EU
Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies.
In-depth understanding of FDA requirements, FDA and MDCG guidance documents, EU MDR, ISO 14971, ISO 13485, Good Clinical Practice, ICH guidelines, and other global regulatory requirements and quality standards.
Excellent negotiation, written, and oral communication skills to effectively interact with regulatory agencies and cross-functional teams.
Strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.
Ability to work independently and under general direction.
Proficiency in MS Office, MS Project, and Adobe Acrobat.
Bachelor’s degree in a scientific discipline or equivalent with 4 years of relevant experience, or an advanced degree with 2 years of experience.

Nice To Haves

5-8 years of industry experience, with at least 2-3 years in regulatory and clinical roles.
Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences).
Experience working in a regulated biotechnology environment, including extensive involvement with regulatory submissions and interactions with regulatory agencies.
History of successful device submissions.

Responsibilities

Develop and refine least burdensome clinical regulatory strategies to support innovations in the Diabetes business with stakeholders across the business—US, EU, international regulatory teams as well as from various partner functions such as reimbursement and R&D.
Maintain proficiency of worldwide regulatory intelligence, including competitor filings, as part of developing innovative clinical regulatory strategies.
Manage projects assigned to support business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products that require clinical evidence.
Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Prepare FDA, European, and rest of world clinical submissions for next-generation diabetes products and product changes that require clinical evidence (i.e. IDEs and Competent Authority)
Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed.
Responsible for the preparation of the clinical portion of submission packages for commercialization (e.g. PMAs, 510k, Technical file dossiers, international submissions, etc.).
Assisting with license maintenance, including annual reports, renewals, design change notifications, and QMS audits.
Follow all work/quality procedures to ensure quality system compliance and high-quality work.
Interact directly with FDA, Notified Bodies, and international regulatory agencies on most projects/products at the reviewer level, with significant issues reviewed with the manager.
Other duties as assigned.