Principal Regulatory Affairs Specialist Job at Katalyst HealthCares and Life Sciences, Marlborough, MA

M1BWMzVXVytueXFWVU83dmpERHFDNlR5
  • Katalyst HealthCares and Life Sciences
  • Marlborough, MA

Job Description

Responsibilities:
  • The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion.
  • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
  • Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
  • Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships.
  • Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration.
  • Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
  • Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
  • Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
  • Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
  • Support and maintain Quality initiatives in accordance with BSC Quality Policy.
  • Continuously assess ways to improve Quality.
  • Develops and implements departmental and divisional policies and procedures.
  • Supports highly technical or major business segment product lines, special projects or strategic initiatives.
Requirements:
  • A minimum of a Bachelor's Degree in a scientific, technical, or related discipline.
  • A minimum of 8 years Regulatory Affairs experience in the medical industry.
  • Prior experience of supporting both the capital equipment as well as single-use disposables.
  • Prior experience with 510(k) submissions, EU MDR and international regulatory registrations.
  • Working knowledge of FDA, EU and international regulations for medical devices.
  • Ability to read and interpret global regulations and standards.
  • General understanding of product development process, design control and quality system regulations.
  • General understanding of regulations applicable to the conduct of clinical trials.
  • Prior experience supporting contract manufacturing and OEM products.
  • Ability to simultaneously manage several projects.
  • Proficiency with Microsoft Office.
  • Effective research and analytical skills.
  • Effective written and oral communication, technical writing and editing skills.
  • Ability to work independently with minimal supervision.
Katalyst HealthCares and Life Sciences

Job Tags

Contract work,

Similar Jobs

PRIDE Health

Travel Nurse RN - Clinical Document Improvement Specialist - $2,520 per week Job at PRIDE Health

 ...Health is seeking a travel nurse RN Clinical Document Improvement Specialist for a travel...  ...Integrity (ICDI) Specialist is accountable for reviewing patient medical records in the inpatient...  ...policies. This Position is 100% Remote can work from anywhere within the U.S.... 

Northrop Grumman

Network Engineer Job at Northrop Grumman

 ...Travel Required: Yes, 10% of the Time Relocation Assistance: Relocation assistance may be available Positions Available: 1 At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today... 

Anderson Paving

Remote Data Typist(Entry Level) Job at Anderson Paving

Job Description As a Remote Data Typist, you'll enter information into database systems, maintain accurate records, and perform various administrative tasks. Responsibilities Data entry and verification Maintaining accurate and up-to-date records Scanning...

Collin College

Art Studios Assistant Job at Collin College

 ...duties and responsibilities. Job Summary: Assist planning, organization, and support daily operations of all Art/Photography studios and coordination of all...  ...Responsibilities Assist students in use of studio/gallery equipment and materials. Assist with the... 

Altimetrik

Senior Python Developer Job at Altimetrik

 ...at this time. We're hiring for Mid to Senior level Python Engineers (US-Remote) Senior: 8 years of experience What youll do: Help translate product requirements...  ...leads, product managers, and other software developers Participating in code and design reviews Becoming...