Senior Regulatory Affairs Specialist

POSITION SUMMARY

The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.

PRIMARY RESPONSIBILITIES

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Understands and interprets U.S. and EU and international medical device and in vitro diagnostic device (IVD) regulatory requirements.

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Provides guidance on requirements to product development teams.

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Develops strategies for submissions to FDA and other regulatory agencies.

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Provides risk assessments and regulatory options.

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Prepares U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements. Prepares and/or compiles information required by ex-U.S. regulatory associates to register or license products outside the U.S. Interacts and negotiates with U.S. regulatory agencies.

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Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.

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Participates in the development and review of product release documents.

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Reviews clinical protocols to assure collection of appropriate data for regulatory submissions.

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Periodically monitors status of clinical studies and reviews analysis of resultant clinical study data.

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Based on these data and considering the regulatory requirements, recommends appropriate courses of action.

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Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies.

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Provides regulatory opinions on premarket regulatory requirements, export, and labeling requirements.

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This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job.

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Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

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Must maintain a current status on the company training requirements.

QUALIFICATIONS

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Bachelor's degree or equivalent; degree in biological sciences, chemistry, or related science strongly preferred.

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Minimum 5 years of experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs or equivalent.

KNOWLEDGE, SKILLS, AND ABILITIES

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Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards.

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Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.

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Ability to organize work, project management experience desirable.

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Remote USA

$83,000 — $103,700 USD

OUR OPPORTUNITY

The company™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The company team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join the company, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, the company employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit [link for members] .

The company is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: [link for members]

Please be advised that the company will reach out to candidates with a @ the company  email domain ONLY. Email communications from all other domain names are not from the company or its employees and are fraudulent. The company does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. The company takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information

• BBB announcement on job scams
• FBI Cyber Crime resource page