Program Director, Compliance & Regulatory Affairs
LOCATION: Remote (US)
TITLE: Program Director, Compliance & Regulatory Affairs
REPORTS TO: Chief Product Officer
TigerConnect is seeking an experienced Sr. Program Manager that will be responsible for the management of quality standards and will follow regulatory requirements for new and existing products to ensure compliance prior to commercialization. This position is also responsible for handling regulatory documents necessary to obtain and maintain US and international clearances, and all regulatory affairs related to the operation of the business. Strong knowledge of FedRAMP, HITRUST certifications and FDA compliance will be essential for someone to succeed in this role.
What You’ll Own:
- Oversees and directs all regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies
- Provides counsel to and manages the regulatory team.
- Ensures timely preparation of organized and scientifically valid applications
- Provides expertise in translating regulatory requirements into practical, workable plans
- Interacts with regulatory agencies, selects, develops, and evaluates personnel to ensure the efficient operation of the function.
- Use analytical skills to assess and monitor company policies related to product quality and regulatory compliance, compose risk assessment reports, analyze and revise related policies, and perform risk assessment of all policies and practices.
- Audit company processes and protocols for flaws and apply remedies, create and maintain a filing system of related records, evaluate marketing and promotional materials to guarantee compliance with applicable regulations, and create and implement compliance strategies for newly developed products.
- Maintain and improve product quality by conducting internal audits, investigating customer complaints, investigating non-conforming products, and overseeing the corrective and preventive action process.
- Analyze product complaints and make recommendations regarding their reportability, and coordinate recall or market withdrawal activities as necessary.
- Authors submissions and other regulatory documents to obtain and maintain US and international clearances
- Identifies relevant guidance documents, international standards, or consensus standards and provides interpretive assistance.
- Recommends changes to company procedures in response to changes in regulations or standards and updates standard operating procedures, work instructions and/or policies.
- Performs other related duties as assigned
What You’ll Bring to the Table:
- 7+ years of experience, particularly as a technical program manager
- Strong knowledge of FedRAMP, HITRUST certifications and FDA compliance
- Experience managing SaaS compliance requirements in the healthcare sector
- Quality system documentation, including policies, procedures, and records
- Developing project plans with regards to cost, resources, timeline, etc.
Who We Are:
TigerConnect is healthcare’s most widely adopted communication platform – uniquely modernizing care collaboration among doctors, nurses, care teams, and patients. TigerConnect is the only solution that combines a consumer-like user experience for both clinical and patient communication with serious security, privacy, and clinical workflow requirements that today’s healthcare organizations demand. TigerConnect accelerates productivity, reduces costs, and improves patient outcomes. Trusted by more than 7,000 healthcare organizations, TigerConnect maintains 99.99% verifiable uptime and processes more than 10 million messages each day. We are recognized as a top Cyber Security Company to Know, one of the 5 Sizzling Silicon Beach Startups to Watch by Entrepreneur, Best Places to Work in Healthcare 5 years in a row (2015, 2016, 2017, 2018, and 2019) and Built In LA’s 2021 Best Places to Work, Best Midsize Companies to Work, Best Paying Companies and Best Perks & Benefits.
Why We’re Different:
- We are the largest provider of clinical communication and collaboration solutions in the U.S.
- We're making much-needed, major changes in the healthcare industry - allowing nurses and doctors to treat more patients, more quickly
- Prime office space in the major tech ecosystems of California - Silicon Beach and Silicon Valley - each complete with a loaded fridge and tons of other perks (think rock climbing wall, food trucks, yoga, happy hours & more)
- An opportunity to work closely with a proven executive team, board, and serial entrepreneurs (www.tigerconnect.com/about)
- A fun environment that embraces a “work hard-play hard” culture
- We have team members that love what they do and are willing to go the extra mile to help clients, support the company's rapid growth, and ultimately optimize healthcare workflows
- This is a full time opportunity with a competitive salary, medical benefits, and 401K matching plan
TigerConnect is an Equal Opportunity Employer.
*Recruiting firms that submit resumes to TigerConnect without first entering into a written contract with TigerConnect will not be entitled to any compensation on candidates referred by that firm.
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