Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

This position will be in Vancouver, WA, Corvallis, OR, Bay Area, CA, or Remote

The Senior Regulatory Affairs Specialist is a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies and managing complex issues that may have significant impact on the business. This critical role advises project and/or product development teams on, and to ensure compliance with, applicable global regulatory requirements. Additionally, as the Senior Regulatory Affairs Specialist you will be responsible for regulatory agency communications regarding pre-submission strategies/ regulatory pathway development, submissions and follow-up on submissions under review (e.g. IDE, PMA, EU MDR submissions).

You will be a part HP's new exciting IVD business and manage global regulatory initiatives and help to develop the regulatory strategy, processes, and infrastructure required to support a new business. You will be working with cross-functional teams to bring new products to the international market, by driving submission content while minimizing the risk of negative actions. This individual is responsible for providing technical expertise and teaching and coaching others on IVD regulatory requirements.

**Responsibilities**

• Lead the business unit in development of processes/procedures for and implementation of new or revised regulatory requirements.
• Develop global regulatory strategies for project teams. Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies.
• Author submissions, including EUAs, 510(k)s, and other international submissions in alignment with pre-market strategies.
• Create and Manage Technical Documentation in compliance with IVDD and IVDR. Work with teams in the US and EU to establish design and manufacturing dossiers for our intended market.
• Communicate with and provide documentation to the Notified Body and Authorized Representative in the EU
• Collaborate with other functions to submit global product registrations. Achieve strategies that focus on speed to market and successful submissions to obtain approval in an efficient timely manner, based on knowledge of the international regulatory landscape.
• Collaborate with and ensure business teams consider the impact of current or emerging regulatory issues; facilitates and ensure company practices are consistent with the corporate risk posture.
• Ensure sound product regulatory strategies including minimizing the risk of negative pre-market submission actions, such as agency review delays.
• Reviews and approves documentation for compliance with US, EU, and other international regulations
• Evaluate and approves proposed changes to products and controlled documents; develops, approves, and implements global regulatory action plans based on the changes. Organize and maintain RA files.
• Review and approve labeling (Instructions for Use, labels, promotional materials) for compliance to standards, guidelines, regulations, and regulatory approvals/clearances.
• Prepares and delivers training programs to the department and other functional groups to ensure compliance.
• Monitor changes in the regulatory environment, evaluates impact, and communicates to interested parties.
• Identifies and manages areas of potential noncompliance
• Participate in the internal audit program and support external audits or inspections
• Other activities as required by the business

**Required Knowledge/Skills, Education, and Experience**

• A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent
• 10+ years experience with a minimum of 4 years of experience in an FDA regulated industry required; preferably with medical devices or IVDs.
• First-hand knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements; Understands: Design Control, In-Vitro Diagnostic Regulation, Essential Requirements, labeling requirements, export requirements, and regulatory requirements of pertinent regions.
• Highly developed writing and interpersonal skills with the ability to work on diverse teams located at different geographical locations
• Demonstrated experience developing effective regulatory strategies
• Ability to apply advanced skills to resolve complex problems not covered by existing procedures or practices independently
• Strong networking and communication skills
• Experience interfacing with government agencies, including the FDA
• Prior experience in submitting EUAs and 510Ks in the US and other international applications
• Good time and project management skills with the ability to multi-task
• Strong leadership skills

**Preferred Knowledge/Skills, Education, and Experience**

• Demonstrated knowledge and understanding of regulations and guidelines governing in-vitro diagnostics.
• RAC certificate

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