Talent.com
Katalyst Healthcares & Life Sciences
Sr. Regulatory Affairs ManagerKatalyst Healthcares & Life Sciences • Minneapolis, MN, United States
Sr. Regulatory Affairs Manager

Sr. Regulatory Affairs Manager

Katalyst Healthcares & Life Sciences • Minneapolis, MN, United States
2 days ago
Job type
  • Full-time
Job description

Senior Regulatory Affairs Manager

The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices.

Responsibilities:

  • Prepare, review, and submit regulatory documents to FDA.
  • Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
  • Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards.
  • Provide regulatory guidance to R&D team during product development life cycle.
  • Stay updated on changes in regulatory requirements and communicate potential impacts to the organization.
  • Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways.
  • Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines.
  • Represent the company in meetings with regulatory agencies and external partners as needed.
  • Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies.

Requirements:

  • Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred.
  • Minimum of 7-10 years of experience in regulatory affairs within the medical device industry.
  • Proven track record of leading and successfully obtaining 510(k) and clearances/approvals.
  • Experience in interacting with FDA and other regulatory agencies.
  • In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
  • Strong leadership and project management skills, with the ability to manage multiple projects and priorities.
  • Excellent communication, negotiation, and problem-solving skills.
  • Ability to work collaboratively in a cross-functional team environment.
  • Detail-oriented with strong organizational skills.
Create a job alert for this search

Sr. Regulatory Affairs Manager • Minneapolis, MN, United States

Similar jobs

Quality and Regulatory Manager

Nonin MedicalMinneapolis, MN, United States
Full-time

Our vision is to improve people's lives by creating noninvasive medical devices people can count on.Nonin's culture is grounded in our mission, and we live by our cultural tenets of courage, owners... Show more

 • Promoted

Healthcare Regulatory Manager - Remote Eligible

Eide BaillyMinneapolis, MN, United States
Remote
Full-time

Location:All locations in the United StatesWork Arrangement:Remote, Hybrid, or In-officeRecent federal legislation introduced mandatory Medicare provider-based attestations and department-level NPI... Show more

 • Promoted

Chemicals SAP Consulting Sr. Manager

ClifyXMinneapolis, MN, United States
Full-time

Location: Chicago, IL Other Locations: MI - Detroit, MN - Minneapolis, OH - Columbus, MA - Boston, NJ - Florham Park, NY - New York, PA - Philadelphia, PA - Pittsburgh.Duration: Full Time Travellin... Show more

 • Promoted

Director/SR Director Product Ops & Execution

Pivot BioMinnetonka, MN, United States
Full-time

Director/SR Director Product Ops & Execution.Fueled by an innovative drive and a deep understanding of microbiology, genomics, crop nutrition, and agriculture, Pivot Bio is pioneering game-changing... Show more

 • Promoted

Sr Manager, Enterprise and Business Performance Analytics (CPG)

General MillsMinneapolis, MN, United States
Full-time

Enterprise Portfolio Performance Leader.We exist to make food the world loves.Our company is a place that prioritizes being a force for good, a place to expand learning, explore new perspectives an... Show more

 • Promoted

Principal Regulatory Affairs Specialist

PhilipsMinneapolis, MN, United States
Full-time

Principal Regulatory Affairs Specialist.Join RespirTech's team in Plymouth, MN as a Principal Regulatory Affairs Specialist, where you will develop and execute global regulatory strategies for inno... Show more

 • Promoted

Pharmacy Senior Director

kpCompaniesMinneapolis, MN, United States
Full-time

Pharmacy Senior Director Hennepin Healthcare.Companies is leading the search for a strategic and collaborative Pharmacy Senior Director to join Hennepin Healthcare.This is an exceptional opportuni... Show more

 • Promoted

Regulatory Affairs Manager - Electrophysiology (on-site)

AbbottMinneapolis, MN, United States
Full-time

Job DescriptionWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.You'll also have access to:Career deve... Show more

 • Promoted

VP Global Quality and Regulatory

TrelleborgMinneapolis, MN, United States
Full-time

VP Global Quality And Regulatory.Trelleborg Medical Solutions is seeking a VP Global Quality and Regulatory, based from their Minneapolis MN headquarters.As a valued team member with Trelleborg, yo... Show more

 • Promoted

Senior Regulatory Affairs Specialist

Boston ScientificMaple Grove, MN, United States
Full-time

Senior Regulatory Affairs Specialist.Work mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): US-CA-Irvine; US-MN-Arden Hills; US-MN-Maple Grove Diversity - Innovati... Show more

 • Promoted

Director of Regulatory Affairs - Remote 2375772 | Eden Prairie, Minnesota | Remote

UMREden Prairie, MN, United States
Remote
Full-time

Director Of Regulatory Affairs.UnitedHealth Group is a health care and well-being company that's dedicated to improving the health outcomes of millions around the world.We are comprised of two dist... Show more

 • Promoted

Assistant Manager

ValvolineAnoka, MN, United States
Full-time

As an Assistant Service Center Manager (ASCM), you are the right hand of the Service Center Manager.You are responsible for taking the lead in helping build a high-performance team capable of diffe... Show more

 • Promoted

Quality/Regulatory Affairs Specialist

Custom Search Inc.Eden Prairie, MN, United States
Full-time

We have partnered with a small start-up company that is looking for someone who's hungry to grow, ready to learn, and excited to be at the center of product quality and regulatory excellence.In thi... Show more

 • Promoted

Director of Regulatory Affairs - Remote 2375772 | Eden Prairie, Minnesota | Remote

divvyDOSEEden Prairie, MN, United States
Remote
Full-time

Director Of Regulatory Affairs.UnitedHealth Group is a health care and well-being company that's dedicated to improving the health outcomes of millions around the world.Here, your contributions mat... Show more

 • Promoted

Senior Regulatory Compliance Consultant

WipfliMinneapolis, MN, United States
Full-time

Wipfli Senior Regulatory Compliance ConsultantAt Wipfli, people count.Our people are core to everything we dothe catalyst behind our ability to create exceptional impact and extraordinary results.W... Show more

 • Promoted

Assistant Store Manager

Frattallones Ace HardwareAndover, MN, United States
Full-time

The Assistant Store Manager has the responsibility for all store activities in the Store Manager's absence.The Assistant Store Manager must exemplify the company's culture through the execution of ... Show more

 • Promoted

Director of Regulatory Affairs - Remote 2375772 | Eden Prairie, Minnesota | Remote

Reliant Medical GroupEden Prairie, MN, United States
Remote
Full-time

Director Of Regulatory Affairs.UnitedHealth Group is a health care and well-being company that's dedicated to improving the health outcomes of millions around the world.Here, your contributions mat... Show more

 • Promoted

1940 Act Regulatory Administration Manager

U.S. BancorpMinneapolis, MN, United States
Full-time

Bank, we're on a journey to do our best.Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and succeed.We b... Show more

 • Promoted

Regional Underwriting Director - Contract Surety

Crum & ForsterMinneapolis, MN, United States
Full-time

Regional Underwriting Director, Midwest Region.The Regional UW Director is responsible for the review and analysis of underwriting data to build and maintain a profitable book of business within th... Show more

 • Promoted

NeuroPsych Regional Specialty Manager - Minneapolis Northwoods

Neurocrine BiosciencesMinneapolis, MN, United States
Full-time

Neurocrine Biosciences Sales Leadership Role.Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing and commercializing life-changing treatments for pati... Show more