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

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.

Please refer the Job description for details