Stryker · 5 hours ago
Staff Regulatory Affairs Specialist, Pharmaceuticals (Remote)
United States
Full-time
Remote
Senior Level, Lead/Staff
$96K/yr - $207K/yr
4+ years expStryker is a leading company in MedSurg, Neurotechnology, Orthopaedics, and Spine, seeking a Staff Regulatory Affairs Specialist in Pharmaceuticals. The role involves supporting regulatory submissions for fluorescence imaging drug products and ensuring compliance with FDA and other regulatory bodies.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Support regulatory submission strategies and update as needed through investigation and evaluation of regulatory history/ background, classification, disease, and/ or harmonized/ recognized standards, in order to assess regulatory implications for approval
Assess the acceptability of quality, nonclinical and clinical documentation for submission filings to comply with regulatory requirements for clinical investigations and marketing applications and corporate goals, to secure submission approval
Prepare submissions and/ or documents supporting submissions (i.e., CTD summaries) to gain approvals for clinical investigations and/ or commercial distribution, such as: CTAs, INDs, ITAs, (s)NDAs, DINAs, Marketing Authorizations (MA) and Letters to File etc
Ensure that the quality, nonclinical and/or clinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, potential regulatory pathways, clarification, and follow-up of submissions under review
Advise personnel on regulatory requirements for quality, nonclinical and clinical data requirements for clinical study applications and/ or marketing applications
Contribute to evaluations of the regulatory environment and provide regulatory input to product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities
Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures
Qualification
Required
Bachelor's Degree
4+ years of experience in an FDA regulated industry
2+ years of pre- and/or post-market Regulatory Affairs experience
Experience preparing submissions and/ or documents supporting submissions (i.e., CTD summaries) to gain approvals for clinical investigations and/or commercial distribution
Ability to comply with constantly changing regulatory and clinical environments and prioritize work effectively
Ability to understand and explain detailed regulatory compliance programs and/or issues
Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment
Preferred
Bachelor's Degree in Health Science or equivalent focus
RAC certification or Advanced Degree (Masters in Regulatory Affairs)
4+ years of regulatory affairs experience within pharmaceuticals
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase