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Manager, Regulatory Affairs Devices


Waltham, Massachusetts

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Job ID 20000H4O

Available Openings 1

PURPOSE AND SCOPE:

Supports FMCNA's new medical device and marketed product development. Oversees preparation of US, Canada, Mexico and other international regulatory submissions for new products, investigates and implements changes to existing products in compliance with applicable international and US federal laws. Provides leadership to a staff of regulatory professionals engaged in preparation of regulatory submissions in support of new product development and changes to existing products. Maintains compliance with US and appropriate international regulatory requirements.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Develops product regulatory approval strategies in collaboration with senior department management. Independently oversee implementation of project plans for assigned products/product lines.
  • Manages assigned Regulatory Affairs devices personnel. Hire, train and develop staff members. Provide timely and appropriate performance feedback.
  • Provides regulatory guidance to product development teams. Advise teams and management on worldwide regulatory requirements.
  • Ensures compliance with US (FDA), Canadian, Mexican and other regulatory submission requirements for medical device registrations.
  • Manages timelines and priorities on all submissions.
  • Ensures that submissions are processed in a timely fashion.
  • Oversees preparation of regulatory assessments for proposed product design changes.
  • Interacts with FDA or other regulatory agencies regarding regulatory strategies for assigned products/product lines.
  • Prepare SOPs to ensure compliance with all applicable US and international regulatory requirements.
  • Provide technical guidance.
  • Assist with various projects as assigned.
  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.


PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • 10 – 15% domestic and international travel required.

SUPERVISION:

May be responsible for the direct supervision of various levels of Regulatory Affairs staff.

EDUCATION:

Bachelor’s Degree required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS:

  • 6 – 8 years’ related experience.
  • 3+ years’ supervisory or project/program management experience preferred. Experience should include effective interaction with manufacturing, quality, clinical/medical and marketing departments.
  • Prior 510(k) experience required.
  • Experience with international regulations preferred.
  • Demonstrated working knowledge of scientific principles.
  • Demonstrated ability to work effectively in a highly charged, fluid environment.
  • Demonstrated ability to independently manage multiple projects.
  • A self-starter with the ability to work as a Project Leader managing projects and allocation of resources to those projects.
  • Very detail-oriented, well-organized, and driven to meet deadlines and program goals.
  • Strong verbal and written communication skills, including the ability to make effective and persuasive presentations.
  • Good computer skills with knowledge of Microsoft Office.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.