Senior Manager - Regulatory Affairs

March 6

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🌽 Illinois – Remote

Although this job is listed in Illinois, this company may be open to hiring remote in other states.

+3 more states

🏄 California – Remote 🌽 Illinois – Remote 🌲 North Carolina – Remote 🦀 Maryland – Remote ☕ Washington – Remote

💵 $137k - $235.8k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Lifelancer

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Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

Life Science • Freelance • Remote Jobs • Healthcare • IT

51 - 200 employees

Founded 2020

🤖 Artificial Intelligence

🧬 Biotechnology

💊 Pharmaceuticals

💰 Pre Seed Round on 2022-03

📋 Description

• The Senior Manager, Regulatory Affairs works closely and partners with internal departments and department management to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). • Combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. • Functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development. • Effectively communicates, prepares, and negotiates both internally and externally with various regulatory agencies. • Properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs. • Collaboratively interface with a variety of levels on significant matters, frequently leading the coordination of activity across organizational units. • Manage, mentor, and develop direct reports to meet individual and company goals and objectives.

🎯 Requirements

• Minimum 10 years’ experience in a regulated healthcare industry with Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years experience; or equivalent experience. • Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred. • Minimum 2 years’ prior management and positive mentorship experience is preferred. • Medical device software engineering background or experience is preferred. • Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations. • Strong knowledge of and experience with pre- and post-market medical device regulations, requirements and submissions including international clinical trial(s) support (e.g., TGA application, ARGT application, Shonin application, Clinical Trial Notification). • Support/experience with quality management system audits for geographies outside of US and EU (e.g., MDSAP, KGMP, Japan QMS, etc.) • Ability to outline sound regulatory strategy in alignment with regulations and business priorities. • Think analytically with excellent problem-solving skills. • Effectively negotiate internally and externally with regulatory agencies. • Clear and effective verbal and written communication skills with diverse audiences and personnel. • Knowledge of business functions and cross group dependencies/ relationships. • Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy of submissions, and all deadlines are met. • Leadership of functional groups in the development of relevant data to complete a regulatory submission. • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues. • Able to effectively and positively lead direct reports while demonstrating flexibility to changing environments. • Proficient in MS Word, Excel, Adobe and Power Point. • Fluency in Japanese or/and Korean language is plus, but not required.

🏖️ Benefits

• medical • dental • vision • life insurance • short- and long-term disability • business accident insurance • group legal insurance • consolidated retirement plan (pension) • savings plan (401(k))