Principal Regulatory Affairs Specialist

March 13

🏄 California – Remote

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

💵 $105k - $194.3k / year

⏰ Full Time

🔴 Lead

🚔 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

• Principal Regulatory Affairs Specialist at Johnson & Johnson - Shockwave Medical. • Works closely with internal departments to meet regulatory requirements. • Develops regulatory policies, strategies, and SOPs. • Determines submission and approval requirements in assigned geographies. • Provides input and technical guidance on regulatory requirements to teams. • Reviews and approves documentation for submission filing. • Interacts and negotiates with regulatory authorities for approvals. • Reviews and approves advertising and promotional materials for compliance. • Evaluates import/export requirements and identifies emerging issues.

🎯 Requirements

• Minimum of 10 years of related experience with a Bachelor’s degree; or 8 years with a Master’s degree; or PhD with 4 years experience; or equivalent experience. • Degree in science, math, engineering, medical or other technical fields preferred. • Class III medical device experience is preferred. • Detailed working knowledge of applicable domestic and international regulatory guidelines, policies and regulations. • Experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, and international filings (TGA, Health Canada, Shonin, CFDA, etc.). • Ability to outline sound regulatory strategy in alignment with regulations and business priorities. • Think analytically with good problem-solving skills. • Clear and effective verbal and written communication skills with diverse audiences and personnel. • Leadership of functional groups in the development of relevant data to complete a regulatory submission. • Some medical device software engineering background or experience is preferred.

🏖️ Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Eligible for consolidated retirement plan (pension) and savings plan (401(k)). • Eligible for long-term incentive program. • Vacation – up to 120 hours per calendar year. • Sick time - up to 40 hours per calendar year; for employees in Washington – up to 56 hours. • Holiday pay, including Floating Holidays – up to 13 days per calendar year. • Work, Personal and Family Time - up to 40 hours per calendar year.