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Regulatory Affairs Specialist 2

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Regulatory & Quality Assurance
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
 
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
 
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
 
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
 
 
Job Summary
  • Assist in the management of all regulatory activities within the defined country/geographical areas by performing the following under supervision of RA management or more senior RA personnel.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 

  • Participate on product development core teams as regulatory representative and provide guidance on global regulatory requirements for new/existing products.
  • Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.
  • Review validation, clinical/R&D protocols and reports to be included or summarized in regulatory submissions.
  • Develop regulatory strategies for domestic and international markets.
  • Assign and track deliverables for submissions from submission content subject matter experts.
  • Write, edit and/publish submission documents by using or creating regulatory templates.
  • Provide regulatory guidance on product design and development plans (labeling, preclinical, and clinical studies), and utilization of standards.
  • Assess manufacturing process, design, and labeling changes for regulatory reporting impact.
  • Keep informed of new and revised regulations; disseminate information as appropriate.
  • Interpret and clearly explain regulatory requirements and standards for IVDs and medical device products to cross-functional stakeholders.
  • Interface with regulatory agencies to clearly present submissions strategies in support of predictable and timely clearance and approvals.
  • Interface with product development teams/sustaining teams and regulatory authorities throughout the product lifecycle.
  • Identify and communicate potential risks of regulatory pathways to the stakeholders.  Work on mitigation plans to reduce regulatory risk when applicable.
  • Prepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned).
  • Provide recommendations for compliant advertising/promotional materials.
Qualifications:
  • Technical knowledge including (but not limited to) Biomedical/Life Sciences/Engineering/Clinical.
  • Understanding of medical device and IVD regulations in US and international markets.
  • Understanding of product life cycle process, design control and/or risk management.
  • Experience using Microsoft Office.
  • Effective technical writing and verbal communication skills.
  • Ability to work as part of a cross-functional team.
  • Ability to work in a fast paced environment with shifting changes in prioritization based on regulatory and business needs.
  • Ability to identify, understand, evaluate, and recommend solutions for complex regulatory problems.
  • Ability to work effectively with teams with limited supervision.
  •  Ability to learn in a fast-paced environment.
  • Ability to make and keep time bound commitments for project completion.
  • Project management skills preferred
  • Understanding of FDA, CE and ROW medical device and IVD regulations. Working knowledge of the medical device product lifecycle. Product design and manufacturing change assessments for regulatory reporting. International regulations and submissions.
Education          
  • Bachelors with 3 years of experience or Masters with 1 year of industry experience or equivalent.
  • Demonstrated success with regulatory submissions [510(k), PMA, Annual reporting, PMA supplements, 30 day notice, etc.] or equivalent.
 
Experience         
  •  Bachelors with 3 years of experience or Masters with 1 year of industry experience or equivalent
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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