Senior Regulatory Affairs Specialist

October 12

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Artera.net

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Description

• About Us: Artera is an AI startup that develops medical artificial intelligence tests to personalize therapy for cancer patients. • As we continue to expand our product portfolio, we are seeking a dynamic and experienced Regulatory Affairs Specialist to ensure our compliance with regulatory standards and streamline the approval process for our products. • The Regulatory Affairs Specialist will be responsible for planning, directing, and coordinating regulatory activities to support Artera’s product development and product maintenance. • The Regulatory Affairs Specialist will play a crucial role in guiding our products through the complex regulatory landscape and will be instrumental in securing regulatory clearances and maintaining compliance with relevant authorities, with a focus on US-based submissions. • This role requires a strategic thinker with a deep understanding of regulatory requirements, excellent leadership skills, and the ability to collaborate cross-functionally to drive successful regulatory strategies. • This position will make a significant impact on the culture, communication, and dynamics of a growing commercial organization.

Requirements

• Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred. • Minimum of 5 years of experience in regulatory affairs within the medical device industry, with a focus on software as a medical device. Experience with AI strongly preferred. • Proven track record of successful regulatory approvals for medical software products, including experience with de novo or 510k submissions. • Experience interacting with the FDA, including eSTAR submissions. • Strong knowledge of global medical device regulations, standards, and guidelines, such as 21 CFR 820, IEC 62304, and ISO 13485. • Familiarity with regulatory requirements for countries that utilize MDSAP. • Understands and complies with ethical, legal, and regulatory requirements applicable to the medical device industry. • Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts to non-technical stakeholders. • Effective leadership, management, and teamwork skills, proactive cross-functional collaborator. • Ability to work independently with minimal oversight and direction. • Ability to effectively manage and prioritize multiple tasks and projects. • Flexibility and adaptability to work in a dynamic and rapidly changing start-up environment. • Expected Travel: <5% domestic.

Benefits

• In addition to base salary, equity is a core component of our compensation. • We also offer 401k matching. • Unlimited paid time off (PTO). • The base salary is competitive and commensurate with experience, qualifications, and other factors to be discussed during the interview process.