Lead Regulatory Specialist - Hologic
Newark, DE
About the Job
Lead Regulatory Specialist
Newark, DE, United States
Are you a strategic leader with a passion for ensuring product safety and compliance in the medical device industry?
We are seeking a dynamic Lead Regulatory Specialist to oversee the preparation and execution of Field Actions for our Breast and Skeletal Health divisions. Based in Newark, DE, this pivotal role requires onsite presence and offers the opportunity to make a significant impact on global recall strategies and regulatory communications.
What You'll Do:
+ Field Action Management :
+ Lead the management and coordination of the preparation and execution of field actions globally.
+ Schedule and facilitate cross-functional meetings to develop plans, deliverables, and ownership for various activities supporting Field Actions.
+ Global Recall Strategies :
+ Collaborate with divisional stakeholders to develop comprehensive global recall strategies and regulatory communications.
+ Coordinate with Hologic international QA/RA representatives to tailor regional recall strategies and regulatory communications.
+ Health Risk and Hazard Evaluations :
+ Develop Health Risk Assessments, Health Hazard Evaluations, and Remedial Action Assessments.
+ Work closely with Quality on processing Field Action records in Agile.
+ Customer and Regulatory Communications :
+ Partner with Marketing, Legal, R&D, Quality, and Regulatory teams to develop customer communications and Hologic field personnel FAQs.
+ Facilitate communications and meetings with regulatory bodies, Notified Bodies, and competent authorities regarding field actions.
+ Tracking and Documentation :
+ Track the effectiveness of field actions, including reconciliation of communications, corrections, and/or removals.
+ Maintain and attach supporting records and documentation to Field Action records.
+ Process Development and Training :
+ Develop and maintain the Field Action process and supporting work instructions.
+ Train personnel on the Field Action process, ensuring compliance with regulatory expectations and industry best practices.
+ Leadership and Supervision :
+ Carry out supervisory responsibilities, including interviewing, hiring, training, and developing employees.
+ Plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints and resolve problems.
Qualifications:
+ Education :
+ Preferred Minimum Technical Degree: BA/BS Degree
+ Experience :
+ Minimum of 10+ years of experience with 21 CFR Part 7 Subpart C – Recalls, 21 CFR Part 806 Medical Device: Reports of Corrections and Removals, FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation regarding field safety corrective actions.
+ Experience with FDA’s Industry Guidance for Recalls and guidance on distinguishing medical device recalls from enhancements.
+ Familiarity with MEDDEV 2.12/1 Guidance on Market Surveillance – Guidelines on Medical Devices Vigilance System.
+ Proven ability to manage multi-source demands for project and product support, fostering an effective team environment.
+ Skills :
+ Ability to assess written product and project documentation as the principal advocate for compliance and effectively communicate assessments.
+ Demonstrates independent decision-making and prioritization, including resolving conflicts and taking leadership roles on critical tasks.
+ Strong capability in guiding teams to assure appropriate and timely completion/resolution of tasks.
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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
The annualized base salary range for this role is $102,600 - $171,000 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.
LI-#DS1
Newark, DE, United States
Are you a strategic leader with a passion for ensuring product safety and compliance in the medical device industry?
We are seeking a dynamic Lead Regulatory Specialist to oversee the preparation and execution of Field Actions for our Breast and Skeletal Health divisions. Based in Newark, DE, this pivotal role requires onsite presence and offers the opportunity to make a significant impact on global recall strategies and regulatory communications.
What You'll Do:
+ Field Action Management :
+ Lead the management and coordination of the preparation and execution of field actions globally.
+ Schedule and facilitate cross-functional meetings to develop plans, deliverables, and ownership for various activities supporting Field Actions.
+ Global Recall Strategies :
+ Collaborate with divisional stakeholders to develop comprehensive global recall strategies and regulatory communications.
+ Coordinate with Hologic international QA/RA representatives to tailor regional recall strategies and regulatory communications.
+ Health Risk and Hazard Evaluations :
+ Develop Health Risk Assessments, Health Hazard Evaluations, and Remedial Action Assessments.
+ Work closely with Quality on processing Field Action records in Agile.
+ Customer and Regulatory Communications :
+ Partner with Marketing, Legal, R&D, Quality, and Regulatory teams to develop customer communications and Hologic field personnel FAQs.
+ Facilitate communications and meetings with regulatory bodies, Notified Bodies, and competent authorities regarding field actions.
+ Tracking and Documentation :
+ Track the effectiveness of field actions, including reconciliation of communications, corrections, and/or removals.
+ Maintain and attach supporting records and documentation to Field Action records.
+ Process Development and Training :
+ Develop and maintain the Field Action process and supporting work instructions.
+ Train personnel on the Field Action process, ensuring compliance with regulatory expectations and industry best practices.
+ Leadership and Supervision :
+ Carry out supervisory responsibilities, including interviewing, hiring, training, and developing employees.
+ Plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints and resolve problems.
Qualifications:
+ Education :
+ Preferred Minimum Technical Degree: BA/BS Degree
+ Experience :
+ Minimum of 10+ years of experience with 21 CFR Part 7 Subpart C – Recalls, 21 CFR Part 806 Medical Device: Reports of Corrections and Removals, FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation regarding field safety corrective actions.
+ Experience with FDA’s Industry Guidance for Recalls and guidance on distinguishing medical device recalls from enhancements.
+ Familiarity with MEDDEV 2.12/1 Guidance on Market Surveillance – Guidelines on Medical Devices Vigilance System.
+ Proven ability to manage multi-source demands for project and product support, fostering an effective team environment.
+ Skills :
+ Ability to assess written product and project documentation as the principal advocate for compliance and effectively communicate assessments.
+ Demonstrates independent decision-making and prioritization, including resolving conflicts and taking leadership roles on critical tasks.
+ Strong capability in guiding teams to assure appropriate and timely completion/resolution of tasks.
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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
The annualized base salary range for this role is $102,600 - $171,000 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.
LI-#DS1
Source : Hologic