Senior Manager, Regulatory Affairs

Location: Remote

Position Scope:

The Senior Manager Regulatory Affairs is responsible for developing key regulatory strategies and executing submissions for new products and markets, timely assessment and reporting on changes for commercialized products, and collaborating with Quality and Operations on compliance issues related to ongoing manufacturing activities. The Senior Manager will also be responsible for monitoring and assessment of global regulation changes and providing leadership to the organization for implementation.  

Strategic Focus Areas:

The Senior Manager Regulatory Affairs will collaborate with Regulatory Affairs leadership to design and implement regulatory strategies for all products, in various jurisdictions, as well as overseeing the implementation of relevant new standards and regulations such as the European Medical Device Regulation

Specific Responsibilities:

  • Independently researches options for regulatory strategies and presents recommendations to senior leadership
  • Plans, analyzes and prepares regulatory submissions for FDA, Europe and other international agencies, and provides guidance to more junior team members for assistance with submissions
  • Manages the collection and coordination of information from non-regulatory functions to prepare regulatory documentation packages for review and submission to regulatory agencies or to our commercial partners
  • Plans, prepares and manages timelines for assigned regulatory documentation including initial submissions, meeting requests, protocol assistance, etc., ensuring that timing is consistent with corporate goals
  • Leads the effort to support design teams and provide submission requirements for gaining marketing approvals in the US and worldwide and supports Design Controls
  • Supports the assessment of regulatory requirements for clinical and preclinical programs to assure that all development activities follow applicable regulations and guidelines
  • Reviews document and product changes for regulatory submission impact and carries out necessary change notification submission requirements as required 
  • Reviews labeling, promotional materials and training materials for regulatory compliance 
  • Manages the compilation materials for license renewals, updates and registrations
  • Understands and communicates US and OUS regulation requirements to other affected functions within the organization; actively reviews new laws/regulatory requirements to maintain proficiency in worldwide regulations and communicates information
  • Provides regulatory review of documentation prior to submission for any external agency or customer, as required
  • Interfaces with safety/regulatory agencies as appropriate
  • Prepares Regulatory Strategy documents for new/improved products as required 
  • Participates on project teams or sub-teams for the planning of activities needed to meet long-term corporate objectives
  • Provides reports on RA submission progress/activities and various other key tasks 
  • Analyzes available information, exercises sound judgment and make appropriate decisions in a timely manner 
  • Provides supervision to reporting regulatory professionals including assignment of tasks and deadlines, performance appraisals and professional development
  • Provides input to budgets, schedules and performance requirements  
  • Other duties as assigned

Job Complexity:

Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current regulatory trends. 

Supervisory Responsibilities:

Provides guidance to junior regulatory staff and consultants; may have direct reports

Required Qualifications:

  • BA/BS in the life sciences or engineering, with MS preferred
  • Requires minimum 10 years of related experience in the medical device/pharmaceutical industry, and minimum 5 years’ regulatory experience
  • Requires experience with complex regulatory submissions for medical devices (IDE, PMA), and combination products. Experience with orthopedic medical devices is desirable
  • 3-5 years of supervisory experience required
  • Experience with international device and drug regulations required
  • Requires initiative, creative, problem-solving ability and superior oral and written presentation skills

Desired Experience, Knowledge, and Skills:

  • Regulatory Affairs Certification preferred
  • Excellent project management skills with the ability to multi-task
  • Effective communication skill to convey or exchange information with internal and external stakeholders in timely manner
  • Ability to work autonomously, effectively manage time and deliver results on time
  • Excellent presentation skills, both written and in platform presentation format

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

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