Regulatory Lead
Company Description
At Biomeme we make things. We make hardware; we work with biological organisms; we hack smartphones. We're looking for passionate people who are skilled with their hands and have impeccable attention to detail. You should be a fast learner and not afraid of tackling challenges both big and small. No task is above or below your pay grade.

Biomeme is as interdisciplinary as it gets. We combine rigorous biology and chemistry with best-in-class hardware and software engineering. It's all wrapped up in sublime user design, with the goal of helping our customers enact real-world change. Guided by data and a belief in the iterative process, we develop elegant solutions to complex problems that demand precision.

Our partners and customers span a wide range of industries across the US, Latin America, Africa and Europe. We've got great traction in health: we're testing for STD's in Philadelphia, Malaria and Ebola virus in Africa, Avian Influenza in Europe, veterinary targets in the Andes and Lyme disease in the US. Outside of health, we have partners in industrial water monitoring, aquaculture, agriculture, conservation biology and more. High school students are testing for mislabeled sushi. Quantified Selfers are tracking their microbiome. Everyday users are even testing their own DNA for genetic markers.

We also recently began work on a multi-year, multi-million-dollar contract with the US Government. It's a good time to come onboard.

Location
Center City, Philadelphia, PA 19107
Employment Type
Full Time
Experience
Mid/High Level
Job Description
Responsibilities:
-Lead, develop and implement regulatory strategy to meet company goals and objectives
-Draft, review, edit, and approve regulatory documents
-Draft, review, edit, and approve documents for Company eQMS
-Provide regulatory oversight and guidance to project teams on compliance matters, labeling, health authority
requirements, and clinical study design issues, logistics, and operational recommendations for product development
-Accountable for the development and submission of regulatory documents (e.g., 510k, PMA, post market surveillance,
responses to regulatory queries, , etc.)
-Facilitate problem-solving and drive decision-making around complex regulatory, preclinical, clinical and development
issues by program teams
-Partner with various other functional groups to plan and execute an effective regulatory strategy in alignment with the
overall product and clinical development plan
-Lead and facilitate meetings with regulatory agencies and prepare internal teams for these interactions
-Ongoing management of the regulatory strategy including regulatory research to stay updated on pertinent regulatory
changes as they affect product development or deployment
-Assist with the identification of hazards and risks and provide input on mitigation strategies
-Identify potential regulatory risks to the strategic/operational plans, and propose options
to mitigate risks
-Provide senior management with strategic advice on potential product lines based on current regulatory landscape

Must have experience in one of these areas (must be able to select adequate resources (e.g. consultants) to assist with knowledge gaps when needed):
In Vitro Diagnostic Medical Devices
FDA (preferred)
EU
Canada
Veterinary Biologics (USDA)
Scientific Equipment/General Consumer electronics
EU (CE-marking)
US (Requirements for commercialization (e.g. FCC).

About You
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Questions
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