Why Hologic:

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.

The Clinical Compliance Specialist 2 Supports Hologic Surgical Division processes for new product and sustaining international clinical evaluations (CEPs and CERs), post-market clinical follow-up documentation (PMCFPs and PMCFRs), and post-market planning and reporting activities (PMSPs, PMRs, PSURs, and Health Canada Annual Summaries.  Serves as medical/technical writer qualified through education and experience to review, evaluate, and determine the adequacy of data from internal and external resources regarding clinical performance and assessment of surgical products’ benefit/risk and “State of the Art” as required to meet European Medical Device Regulation literature search deliverables. Works with other experts (eg, professional partners) as needed to finalize and document Hologic determinations

What to expect:

Medical/technical writer qualified through education and experience to review, evaluate, and determine the adequacy of data from internal and external resources regarding clinical performance and assessment of surgical products’ benefit/risk and “State of the Art” as required to meet European Medical Device Regulation deliverables.  Support new product development core teams including development of clinical regulatory content for domestic and international submissions for medical devices.  Develop and execute strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on a regular basis. Provide clinical regulatory support to existing and new cross-functional product core teams. Ensure high-quality documentation is properly catalogued in quality management systems.  Maintain records for annual reporting of Sunshine Act payments.

What we expect:.

Demonstrate Knowledge of Clinical Evaluation and Post Market Activities per EU MDR 2017/745, MEDDEV 2.7.1/Rev 4, and other MDCG guidance specific to Clinical Evaluation and PMS/PMCF Activities. Ability to manage project teams under designated timelines Strong oral and written communication and presentation skills. Ability to evaluate published clinical literature.  Knowledge and understanding of medical and clinical terminology and levels of evidence.  Demonstrated ability to coordinate complex projects.  Firm understanding of regulatory issues in the medical device space and GCP.  Good analytical, critical thinking and problem-solving skills. Demonstrate understanding of advanced technical/scientific principles related to medical device safety and performance. 

Education & Experience:

Preferred Minimum Non-Technical Degree: College Degree A minimum of 4 years of experience in medical/scientific/clinical writing or Regulatory Affairs. Previous experience authoring/supporting CER, CEP, PMCF, PSUR documents required.  Subject matter expert on CER, CEP, PMCF, PSUR desired. 

The annualized base salary range for this role is $77,000 to $120,000 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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