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Senior Manager, Regulatory Affairs

Employer
Inflammatix, Inc.
Location
Sunnyvale, CA (Hybrid)
Start date
Sep 23, 2022

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Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

Inflammatix is seeking a Senior Manager, Regulatory Affairs  to collaborate on multiple submissions in a nascent Regulatory Affairs team. This position reports to the Head of Regulatory Affairs. The Senior Manager Regulatory Affairs contributes to establishing global regulatory strategy in collaboration with cross functional stakeholders and is responsible for timely execution of the strategy for new and existing products to ensure compliance with global regulatory requirements.

POSITION SUMMARY:

  • Support the development and implementation of strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, and marketing applications
  • Ensure timely preparation of organized and scientifically valid applications; provide expertise in translating regulatory requirements into practical, workable solutions
  • Provide input into post-market activities, including complaint handling, adverse event reporting and field corrects/recalls

PRIMARY RESPONSIBILITIES:

  • Support meeting regulatory responsibilities associated with the development, support, and manufacturing of the Company’s medical device products
  • Support the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation of submissions to achieve timely and cost-effective clearance/approval
  • Provide information for maintaining registrations and listings
  • Monitor and assess Regulatory developments (e.g., Federal Register publication/notices, FDA guidelines, etc.) and change management related to the Company’s products
  • Review product labeling to ensure conformance with Regulatory requirements and/or approved product claims
  • Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle
  • Support internal and external audits; collaborate with Quality Assurance to coordinate strategy and provide responses to audit requests and inquiries
  • Write and implement appropriate procedures and processes as needed

MINIMUM QUALIFICATIONS:

  • Bachelor's degree in a physical or life science related fields
  • A minimum of 5 years regulatory affairs experience in the medical device industry
  • Experience with ISO 13485:2016 and 21 CFR Part 820
  • Experience with IVDD and IVDR requirements
  • Experience preparing technical documents and submission dossiers
  • Experience with IVD 
  • Broad knowledge of and experience with US, EU, and Rest-of-World medical device registration processes (preferred)
  • Regulatory Affairs certificate from RAPS or other organization (preferred)
  • Experience with 510(k) submission (preferred)

KNOWLEDGE, SKILLS, AND ABILITIES:

  • High ethical standards and integrity
  • Ability to work well independently and in a team environment, interact productively, and effectively with peers, management, and third parties
  • Proficiency with Microsoft Office including Word, Excel, and PowerPoint
  • Excellent written and verbal communication skills; attention to details
  • Ability to maintain a high level of confidentiality
  • Use resources effectively and reasonably
  • Perform other duties and assignments as required

COMPENSATION AND CLASSIFICATION:

  • Classification: Full-time position
  • Compensation: Competitive and commensurate with experience; equity package
  • Benefits: Medical, dental, and vision; 401(k) and more

Inflammatix requires all employees to be vaccinated against COVID-19 (subject to any legally protected exemptions).  For travel, Inflammatix requires compliance with all applicable local and national health and safety guidelines.

Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.

 

Notice to Agencies:

Our internal Talent Acquisition Team manages all career opportunities.   Agencies and independent recruiters must be approved as a vendor by the Legal and Talent Acquisition teams at Inflammatix before submitting candidates (for any current or future positions) to any employee of Inflammatix. We do not accept unsolicited resumes or profiles from agencies or independent recruiters under any circumstances.  Inflammatix will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume or profile.  Please do not contact Inflammatix employees directly. Compliance with this request will impact our decision to engage or work with you or your agency and/or representatives in the future.

Company

Inflammatix is developing an innovative point-of-care instrument platform to be used with a rapid (<30-minute) test to aid in the diagnosis of acute infection and sepsis by harnessing the immune system to deliver advanced immune response diagnostics. Our HostDx test rapidly informs the clinician about the likelihood of bacterial or viral infection and the need for ICU level care in the emergency department. Faster results may translate into more timely and appropriate therapy and level of care decisions for better patient outcomes. 

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Find Us
Website
Phone
(650) 443-3030
Location
540 Oakmead Pkwy
Sunnyvale
CA
94085
United States
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