Medical Device Reporting Specialist - Marlborough, MA

Job Summary:

We are seeking a detail-oriented and proactive Medical Device Reporting Specialist to join our dynamic team. This role is critical in ensuring compliance with applicable regulations and quality management systems (QMS) requirements, specifically related to the assessment, documentation, and reporting of adverse events and serious injuries. The incumbent will be responsible for preparing and submitting reports to Regulatory Agencies, coordinating with cross-functional teams, and maintaining adherence to international regulatory standards.

Key Responsibilities:

• Assess potential adverse events in accordance with applicable regulations and QMS requirements.
• Timely submission of Adverse Event/Serious Injury reports, including MedWatch notifications and other relevant reports to Notified Bodies, Regulatory Agencies, and other sources.
• Prepare and submit responses to Regulatory Agencies when follow-up questions are received.
• Collaborate with cross-functional partners to gather necessary information for adverse event assessments and regulatory responses.
• Contact end users or complaint points of contact for additional required information as applicable.
• Ensure the completion and documentation of Good Faith efforts within the QMS in a timely manner.
• Liaise with the International Quality group to ensure compliance with international adverse event reporting requirements.
• Monitor, analyze, and communicate Key Process Indicators (KPIs) related to adverse event/serious injury reporting.
• Identify and escalate adverse trends to management for potential corrective actions.
• Initiate and lead corrective actions as needed.
• Support preparation for internal and external audits, acting as a Subject Matter Expert (SME) when required.
• Assist in training employees within the Quality organization on medical devices developed and distributed by the GSS division, including product indications and environmental considerations for treatment

Experience:

• 2-5 years progressive quality experience in Medical Device or related Industry.
• Bachelor’s Degree in Medicine, Nursing or Biomedical engineering preferred. Candidates certified as Risk Managers can also be considered.
• Understanding and strong knowledge of applicable regulations and standards, in particular, ISO13485 and 21CFR Part 820 and EU Medical Device Regulation.
• Travel Expected 20%

Skills: 

• Excellent communication, organization and problem solving skills.
• Ability to work effectively with cross functional teams and external stakeholder. Experience using program management tools to ensure deliverables are completed based on specific due dates.
• Excellent attention to detail to ensure accuracy and thoroughness of documentation an reporting.
• Proactively identifies and addresses issues, leading corrective actions as needed. 
• Proficient in the use of product lifecycle management (PLM) tools.
• Proficient in the use of Microsoft Office Suite.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

Role is located in Marlborough, MA or Denver, CO

The annualized base salary range for this role is 83,00-129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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