Senior PSUR Writer

This is a fully remote position, open to applicants in Connecticut, +1 more state.

📋 Description

• Oversee the creation, evaluation, and upkeep of PSURs, PMSPs, PMSRs, and associated post-market surveillance documentation.

• Effectively manage multiple product families and corresponding report cycles concurrently.

• Analyze and interpret data from complaints, vigilance reports, clinical literature, CAPA, trends, and risk management to support safety evaluations.

• Create detailed safety narratives, conclusions, and risk-benefit assessments.

• Act as the principal cross-functional contact for PSUR development initiatives.

• Ensure adherence to EU MDR 2017/745, FDA standards, ISO 13485, and ISO 14971 guidelines.

• Detect safety signals, emerging trends, and potential regulatory hazards.

• Offer recommendations for updates to risk management files and surveillance strategies.

• Lead the creation, execution, and maintenance of global procedures, work instructions, templates, and best practices relating to PMSPs, PMSRs, and PSURs.

• Develop and uphold standardized authoring templates across product lines.

• Identify deficiencies in PMS processes and initiate improvements for efficiency, inspection readiness, and regulatory adherence.

• Provide training and support to cross-functional teams on PSUR processes, procedures, and documentation requirements.

• Collaborate with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Risk Management on the lifecycle management of PMS documentation.

• Mentor and offer technical assistance to novice PSUR writers and other team members.

• Assist with regulatory inspections, audits, and responses concerning PMS documentation.

• Deliver findings and status updates to management and cross-functional teams.

• Raise significant compliance risks, resource issues, and timeline concerns.

• Perform additional duties as assigned.

⛳️ Requirements

• In-depth knowledge of EU MDR 2017/745, FDA regulations, ISO 13485, ISO 14971, and post-market surveillance standards.

• Exceptional scientific and technical writing skills.

• Capability to independently interpret intricate safety, clinical, and quality data.

• Strong project leadership and stakeholder management abilities.

• Excellent analytical, critical-thinking, and problem-solving skills.

• Experience in leading cross-functional projects.

• Advanced proficiency in Microsoft Office and document management systems.

• Solid understanding of medical device risk management principles and post-market surveillance processes.

• Ability to mentor and train junior team members.

• Minimum of 5 years of experience in Medical Writing, Regulatory Affairs, Post-Market Surveillance, Pharmacovigilance, Clinical Affairs, or Quality Assurance within the medical device sector.

• At least 3 years of experience in authoring PSURs, PMSRs, PMS Plans, CERs, or equivalent regulatory documentation.

• Proven experience in independently leading complex regulatory writing projects.

• Bachelor's degree required in a scientific, technical, engineering, healthcare, or related field.

• Advanced degree preferred.

• Ability to work remotely in the US.

• May require 0-5% domestic and/or international travel.

🏝️ Benefits

• Medical coverage.

• 401(k) plan.

• Parental leave.

• Fertility benefits.

• Paid time off for vacation, personal, sick days, and holidays.

• Additional perks and benefits.

• Potential eligibility for other types of compensation and benefits.