"Alerted.org

Sr Director, Medical Safety Officer

San Diego, CA, United States

Marlborough, MA, United States

Hologic's Quality team is seeking a Medical Safety Officer responsible for providing medical safety stewardship for global Hologic portfolio of products. This role involves collaboration with cross-functional teams to assess potential safety signals and implement risk management strategies. The MSO will serve as a subject matter expert in patient risk management throughout the product lifecycle, ensuring proactive and flexible risk management systems are in place. The position requires strong relationships with various departments to evaluate customer/user risk and assess the impact of product performance issues on patient safety.

Knowledge

+ Comprehensive understanding of medical risk evaluation, mitigation strategies, and patient safety principles.

+ Expertise in clinical practices, particularly in Breast/GYN or General Surgery.

+ Strong knowledge of medical device regulations, compliance standards, and risk management processes.

+ Familiarity with basic statistical techniques, epidemiological principles, and data interpretation.

+ Awareness of digital medicine and artificial intelligence integration in medical devices.

Skills

+ Advanced ability to assess product risk-benefit profiles and interpret post-market safety data.

+ Proficiency in evaluating adverse events, complaints, and conducting health hazard assessments.

+ Effective communication and interpersonal skills for collaboration with cross-functional teams, customers, and regulators.

+ Leadership skills to guide audits, regulatory interactions, and field action processes.

+ Analytical and critical thinking skills for clinical study design, risk assessments, and safety evaluations.

Behaviors

+ Detail-oriented and analytical, with a focus on ensuring patient safety and product performance.

+ Collaborative and team-oriented, promoting partnerships across departments and stakeholders.

+ Proactive and adaptable, thriving in a dynamic and fast-paced environment.

+ Ethical and professional, ensuring compliance with regulatory and legal standards.

+ Innovative and forward-thinking, with a commitment to improving healthcare outcomes.

Experience

+ MD designation or equivalent, with at least 5 years of clinical experience as a Breast/GYN or General Surgeon.

+ Experience in risk evaluation, medical devices, or the life sciences industry.

+ Proven track record of interfacing with senior leadership in a global healthcare company.

+ Clinical study/research experience and familiarity with digital medicine/AI integration are advantageous.

Why join Hologic?

We are committed to making Hologic the destination for top talent. 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.

The annualized base salary range for this role is $195,900- $348,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, 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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