Johnson & Johnson Innovative Medicine logo
Johnson & Johnson Innovative Medicine

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Post Market Specialist II

Medical ReviewerMedical ReviewerFull TimeRemoteMid LevelTeam 10,001

Location

United States

Posted

11 days ago

Salary

$79K - $127.7K / year

Seniority

Mid Level

No structured requirement data.

Job Description

Post Market Specialist II

Johnson & Johnson Innovative Medicine

Role Description The Post Market Complaint Specialist II is responsible for reviewing clinical and product complaints to assess for reportability in compliance with global medical device regulations. The candidate must have experience in medical device and post-market regulations with a solid understanding of complaint handling processes and adverse event follow-up. - Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment. - Completes assessments of product complaints to determine reportability and coordinates complaint investigations between the quality assurance department, engineering, customer support and other departments. - Review all assigned clinical and product complaints for adverse events. - Interface with field reps and clinical staff to acknowledge, document and obtain detailed information regarding adverse events and incidents received by the company. - Apply knowledge of medical device regulatory requirements to support the reporting decision process and identify reportable events as they are received. - Perform data entry and prepare reports/graphs related to special projects, complaints and lot qualification as necessary. - Complete Reportability Assessments in a timely manner in adherence with Abiomed’s policies and procedures. - Identify possible trends related to complaints and present information or concerns to management using available programs and applications (e.g. PowerPoint, Excel, graphs, charts). - Escalate complex complaint issues per department policies and guidelines. - Work closely with engineering investigation teams to ensure the timely closure of technical investigations. - Interact with cross-functional teams to obtain information pertinent to the complaint investigation. - Write customer letters. Qualifications - Minimum 3+ years of work experience processing complaints within the device and/or pharmaceutical/life-sciences industry. - Bachelor’s degree: Medical device experience preferred. - Demonstrated knowledge of global medical device and/or pharmacovigilance regulations. - Working knowledge/experience with domestic and international regulatory reporting requirements for medical devices (i.e. 21CFR 803, CMDR, Meddev 2.12, etc.) (experience with PMDA highly preferred). - Excellent written, verbal & interpersonal communication skills. - Proficient in the use of Microsoft Office programs, specifically Excel, PowerPoint, Word. - Approachable with a positive attitude. - Critical thinker. - Exceptional attention to detail in documenting events, composing clinical narratives, and editing quality documents. - Demonstrated ability to manage multiple competing priorities and meet deadlines. - Ability to work independently and as a team player. - Experience using a global complaint handling database or quality management system e.g. Trackwise, Salesforce. - Possess strong complaint handling experience (i.e. 21CFR 820.198). Requirements - Applicants must provide proof that they are fully vaccinated with an FDA approved or authorized vaccine for COVID-19 or have a valid medical/religious exemption. Benefits - Vacation – 120 hours per calendar year. - Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year. - Holiday pay, including Floating Holidays – 13 days per calendar year. - Work, Personal and Family Time - up to 40 hours per calendar year. - Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child. - Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year. - Caregiver Leave – 80 hours in a 52-week rolling period. - Volunteer Leave – 32 hours per calendar year. - Military Spouse Time-Off – 80 hours per calendar year.

Related Categories

Related Job Pages

More Medical Reviewer Jobs

Simsy Ventures logo

Physician, Medical Case Reviewer

Simsy Ventures

A builder, an institutional co-founder & a partner from ideas to new startups, ventures & beyond 🚀

Medical Reviewer11 days ago
Part TimeRemoteTeam 11-50Since 2022H1B No Sponsor

• Conduct objective medical case reviews using standardized assessment criteria • Evaluate the timeliness and appropriateness of care provided • Identify quality improvement opportunities • Review cases initiated for non-standardized performance improvement reasons • Assess medical decision-making and compliance with best practices • Provide expert medical opinions • Analyze complex clinical scenarios from an impartial, evidence-based perspective

United States
Cohere Health logo

Medical Reviewer

Cohere Health

Cohere Health is a Software-as-a-Service (SaaS) company focused on improving the patient journey by enhancing the quality of care at lower costs, as well as emp

Medical Reviewer12 days ago
Full TimeRemoteTeam 900Since 2019

Role Description We are looking for an orthopedic spine Physician Assistant to help deliver on Cohere’s musculoskeletal and orthopedic programs by determining the medical appropriateness of services by reviewing clinical information and applying evidence-based guidelines. The physician assistant should have previous experience in managing spine conditions in an office setting as well as assisting on spine cases in the operating room. This is a remote-first role that may require travel to Boston, MA for new hire onboarding and occasional in-person team meetings and company events. What you’ll do: - Provide timely medical reviews that meet Cohere’s stringent quality parameters - Provide clinical determinations based on evidence-based criteria while utilizing clinical acumen - Clearly and accurately document all communication and decision-making in Cohere workflow tools, ensuring a member and provider can easily reference and understand your decision - Use correct templates for documenting decisions during case review - Meet the appropriate turn-around times for clinical reviews - Demonstrate the highest level of professionalism, accountability, and service in your interactions with Cohere teammates and providers - Support projects specific to building the team's clinical expertise and efficiency, as delegated - Support the team on operational improvements and member/provider experience involving clinical review tasks, as delegated - Clearly communicate with team members Qualifications - Graduate of an accredited Physician Assistant program - Current NCCPA certification (PA-C) and active, unrestricted Physician Assistant license in at least one U.S. state - 3+ years of clinical experience supporting orthopedic spine surgeons and/or neurosurgeons treating spine conditions - Utilization management, prior authorization, or medical review experience a plus - Membership in organizations such as the AAPA or specialty spine organizations Benefits - Fully remote opportunity with about 5% travel - Medical, dental, vision, life, disability insurance, and Employee Assistance Program - 401K retirement plan with company match; flexible spending and health savings account - Flex Time Off + company holidays - Up to 14 weeks of paid parental leave - Pet insurance The salary range for this position is $120,000 to $135,000 annually; as part of a total benefits package which includes health insurance, 401k and bonus. In accordance with state applicable laws, Cohere is required to provide a reasonable estimate of the compensation range for this role. Individual pay decisions are ultimately based on a number of factors, including but not limited to qualifications for the role, experience level, skillset, and internal alignment. Interview Process - Connect with Talent Acquisition for a Preliminary Phone Screening - Meet your Hiring Manager! - Behavioral Interview(s) Company Description Cohere Health’s clinical intelligence platform and agentic AI-powered solutions connect health plans’ strategic goals and providers’ needs, optimizing the speed, cost, and quality of care. With an enterprise approach that streamlines payer-provider decision-making across the care continuum–including policy, prior authorization, payment accuracy, and more–the company improves collaboration and reduces burden, resulting in up to 8x ROI and 94% provider satisfaction. Cohere Health’s innovations continue to receive industry wide recognition. We’ve been named to the 2025 Inc. 5000 list and in the Gartner® Hype Cycle™ for U.S. Healthcare Payers (2022-2025), and ranked as a Top 5 LinkedIn™ Startup for 2023 & 2024. The Coherenauts, as we call ourselves, who succeed here are empathetic teammates who are candid, kind, caring, and embody our core values and principles. We believe that diverse, inclusive teams make the most impactful work. Cohere is deeply invested in ensuring that we have a supportive, growth-oriented environment that works for everyone. We can’t wait to learn more about you and meet you at Cohere Health! Cohere Health is an Equal Opportunity Employer. We are committed to fostering an environment of mutual respect where equal employment opportunities are available to all. To us, it’s personal.

United States
$120K - $135K / year
Dane Street logo

Board Certified Disability Peer Physician Reviewer – Medical Oncology

Dane Street

National Provider of IME and Medical Peer Review Services

Medical Reviewer12 days ago
ContractRemoteTeam 51-200H1B No Sponsor

• Evaluate and review disability claims • Conduct reviews from the convenience of home • Participate in a flexible scheduling environment

United States
Dane Street logo

Medical Advisory Reviewer – Orthopedic Surgery

Dane Street

National Provider of IME and Medical Peer Review Services

Medical Reviewer12 days ago
ContractRemoteTeam 51-200H1B No Sponsor

- Apply your expertise to conduct comprehensive reviews of clinical cases - Provide objective, evidence-based medical opinions - Review medical records and prepare clear and concise clinical summaries - Respond to specific questions from clients related to Orthopedic Surgery care

Ohio