Regulatory Affairs Expert

18 hours ago

Indianapolis, Indiana, United States Lifelancer Full time

Company Overview

Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT domains.

Salary

The estimated annual salary for this position ranges from $102,000 to $128,000, depending on skills, experience, and location.

Job Description

Position Overview

The Principal Regulatory Affairs Specialist plays a key role in ensuring that products meet regulatory requirements. This individual contributor works closely with internal departments to efficiently meet assigned regulatory deadlines, particularly for the Reducer product business at Shockwave Medical Inc.

This specialist combines knowledge of scientific, regulatory, and business issues to guarantee that products are developed, manufactured, and distributed according to regulatory standards. Under the direction of responsible Regulatory Affairs Management, they work independently with minimal oversight, making decisions on regulatory matters, ensuring timely registration and renewal, and supporting new product development as assigned.

Key Responsibilities

  • Collaborate with various levels on significant matters, often requiring coordination across organizational units.
  • Develop regulatory policies, processes, and SOPs, and may train key personnel on them.
  • Determine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholders.
  • Provide input and technical guidance on regulatory requirements to product development and operations teams.
  • Work with product development, quality, and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents).
  • Review and approve RD, quality, preclinical, and clinical documentation for submission filing.
  • In collaboration with cross-functional team members, compile, prepare, review, and/or submit regulatory submissions to authorities and coordinate/communicate with distributors and other agencies for filing purposes mainly focused outside the US, as assigned.
  • Interact and negotiate with distributors, authorized reps, in-country staff, and directly with regulatory authorities during the submission and review process to ensure submission approvals.
  • Evaluate proposed design, clinical, and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements.
  • Oversee the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies.
  • Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
  • Provide regulatory input for product recalls and recall communications.
  • Review and approve advertising and promotional materials to ensure regulatory compliance.
  • Evaluate import/export requirements.
  • Identify emerging issues.
  • Provide other country-specific regulatory support.
  • Effectively and accurately write and edit technical documents.
  • Plan and conduct meetings, create project plans and timelines, and manage projects.
  • Exercise good and ethical judgment within policy and regulations.
  • Perform multiple tasks concurrently with accuracy.
  • Provide guidance to functional groups in the development of relevant data to complete a regulatory submission.

Requirements

  • A minimum of 10 years of related experience with a Bachelors degree; or 8 years and a Masters degree. A degree in science, math, engineering, medical, or other technical fields and Class III medical device experience are preferred.
  • Ability to work collaboratively in a fast-paced environment while managing multiple priorities.
  • Detailed working knowledge of applicable domestic and international regulatory guidelines, policies, and regulations.
  • Experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, and international filings (TGA, Health Canada, Shonin, CFDA, etc.).
  • Ability to outline sound regulatory strategy in alignment with regulations and business priorities.
  • Think analytically with good problem-solving skills.
  • Effectively negotiate internally and externally with regulatory agencies.
  • Clear and effective verbal and written communication skills with diverse audiences and personnel.
  • Knowledge of business functions and cross-group dependencies/relationships.
  • Leadership of functional groups in the development of relevant data to complete a regulatory submission.
  • Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues.
  • Operate as a team and/or independently while demonstrating flexibility to changing requirements.
  • Some medical device software engineering background or experience is preferred.
  • Proficiency in MS Word, Excel, and Power Point required.

Benefits

Shockwave Medical offers a competitive total compensation package, including core benefits like medical, dental, vision, pre-tax and Roth 401k options with a fully vested match, short-term and long-term disability, and life insurance, employer contribution toward Health Savings Account (HSA), and competitive PTO balance. Additional perks include Calm App, Pet Insurance, Student Loan Refinancing, and Spot Bonus awards.

  • Regulatory Affairs Specialist

    1 month ago

    Indianapolis, Indiana, United States Roche Full time

    About RocheRoche is a leading research-focused healthcare group with a presence in over 100 countries. Our mission is to push back the frontiers of healthcare and improve people's lives.The RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Roche Global Regulatory Affairs. As a key member of our team, you will be responsible...

  • Regulatory Affairs Specialist

    4 weeks ago

    Indianapolis, Indiana, United States Lifelancer Full time

    Job Title: Principal Regulatory Affairs SpecialistAbout the Job:At Lifelancer, we are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Develop...

  • Regulatory Affairs Specialist

    4 weeks ago

    Indianapolis, Indiana, United States Lifelancer Full time

    Job DescriptionAt Lifelancer, we are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Develop and implement regulatory strategies to ensure...

  • Corporate Paralegal

    3 weeks ago

    Indianapolis, Indiana, United States Jobot Full time

    Job SummaryWe are seeking a highly skilled Corporate Paralegal to join our dynamic team in the Manufacturing industry.This is a permanent, full-time position that offers a unique opportunity to work closely with our legal team and various departments within the organization.Main ResponsibilitiesAssist in managing company-wide compliance programs and...

  • Research Regulatory Coordinator

    1 month ago

    Indianapolis, Indiana, United States Indiana Hemophilia & Thrombosis Center, Inc. Full time

    Job Title: Research Regulatory CoordinatorAt Indiana Hematology & Thrombosis Center, Inc., we are seeking a highly skilled Research Regulatory Coordinator to join our team.Job Summary:The Research Regulatory Coordinator will be responsible for ensuring compliance with regulatory requirements and guidelines related to clinical research. This includes...

  • Corporate Paralegal

    4 weeks ago

    Indianapolis, Indiana, United States Jobot Full time

    Job Title: Corporate Paralegal - Chemical Manufacturing ExpertJob Summary: We are seeking a highly skilled Corporate Paralegal to join our team at Jobot. The ideal candidate will have a strong background in corporate law and compliance, with excellent research and writing skills.Key Responsibilities:Manage regulatory filings and maintain corporate...

  • Production Labelling Project Manager

    4 weeks ago

    Indianapolis, Indiana, United States Hoffmann-La Roche Ltd Full time

    About the RoleAs a key member of the Global Labeling Near Patient Care team at Hoffmann-La Roche Ltd, you will play a critical role in ensuring the successful development, design, and localization of content for user's manuals and packaging for people with diabetes worldwide.This is an exciting opportunity to leverage your project management expertise and...

  • Medical Technologist

    4 weeks ago

    Indianapolis, Indiana, United States Veterans Affairs, Veterans Health Administration Full time

    Job SummaryThe incumbent serves as a Medical Technologist within the Blood Bank, Hematology, and Coagulation sections of the Pathology and Laboratory Medicine Service at the Richard L. Roudebush VA Medical Center. This is considered entry-level for nonsupervisory positions.ResponsibilitiesUtilizes comprehensive knowledge of professional medical...

  • Registered Dietitian

    4 weeks ago

    Indianapolis, Indiana, United States Elior North America Full time

    Job Title: Registered Dietitian - Healthcare Nutrition ExpertWe are seeking an experienced Registered Dietitian to join our team at Elior North America. As a Registered Dietitian, you will play a crucial role in identifying and assessing the nutritional needs of our patients and residents, initiating interventions to achieve and/or maintain their nutritional...

  • Clinical Pharmacist

    1 month ago

    Indianapolis, Indiana, United States Eskenazi Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Pharmacist to join our team at Eskenazi Health. As a key member of our healthcare team, you will provide expertise in the medication use process and optimize medication regimens for hospitalized patients.Key ResponsibilitiesOptimize medication regimens for assigned patients by collecting necessary...

  • Data Quality Specialist

    1 month ago

    Indianapolis, Indiana, United States Global Channel Management Full time

    About the JobThe IT Data Quality Consultant plays a crucial role in ensuring the accuracy and reliability of data across the organization.Key ResponsibilitiesCollaborate with data management subject matter experts to drive improvements in data-related standards, processes, and governance.Partner with functional area data experts to anticipate and resolve key...

  • Mechanical Engineer

    4 weeks ago

    Indianapolis, Indiana, United States TRC Worldwide Engineering Full time

    Job SummaryWe are seeking an experienced Mechanical Engineer with expertise in HVAC engineering for building systems. The ideal candidate will have a strong background in designing, preparing specifications, and reviewing mechanical engineering for building systems, including HVAC, Plumbing, and Fire Protection.Key ResponsibilitiesDesign and prepare...

  • Chemist - Quality Control Specialist

    4 weeks ago

    Indianapolis, Indiana, United States BioSpace, Inc. Full time

    Job SummaryThe Chemist - Quality Control position at BioSpace, Inc. is responsible for performing accurate and timely testing of routine and investigative lab samples in accordance with appropriate GMP and safety guidelines. This role requires a strong understanding of cGMP requirements in API manufacturing and the ability to troubleshoot equipment and...

  • Marketing Product Manager

    4 weeks ago

    Indianapolis, Indiana, United States S&T Bancorp Full time

    Job SummaryWe are seeking a highly skilled Marketing Product Manager to lead our deposit growth efforts. As a key member of our consumer banking team, you will be responsible for developing and executing marketing strategies to drive deposit acquisition, deepening, and retention.Key ResponsibilitiesDevelop and implement marketing strategies to achieve...

  • Senior Civil Engineer

    4 weeks ago

    Indianapolis, Indiana, United States Atlas Technical Consultants Full time

    Solid Waste Management ExpertiseWe are seeking an experienced Senior Civil Engineer to lead and manage solid waste design projects in Indiana and Ohio. The successful candidate will be responsible for overseeing the design, permitting, and construction of solid waste facilities, including landfills, transfer stations, and recycling facilities.Key...

  • Advanced Laboratory Medical Technician

    4 weeks ago

    Indianapolis, Indiana, United States Veterans Affairs, Veterans Health Administration Full time

    Job SummaryThe Advanced Laboratory Medical Technician will serve as a key member of the Send-Outs/Processing Section within the Pathology and Laboratory Medicine Service at the Richard L. Roudebush VA Medical Center. This role will be responsible for performing complex diagnostic tests, evaluating specimen suitability, and maintaining open communication with...

  • Staff Pharmacist

    4 weeks ago

    Indianapolis, Indiana, United States CVS Health Full time

    At CVS Health, we're committed to delivering enhanced human-centric healthcare for a rapidly changing world. As a Staff Pharmacist, you'll play a critical role in transforming our culture and accelerating our ability to innovate and deliver solutions to make healthcare more personal, convenient, and affordable.As a key member of our pharmacy team, you'll be...

  • Mortgage Loan Officer

    1 month ago

    Indianapolis, Indiana, United States Financial Center First Credit Union Full time

    Job SummaryFinancial Center First Credit Union is seeking a skilled Mortgage Loan Officer to join our team. As a Mortgage Loan Officer, you will be responsible for guiding members through the mortgage loan application process, from initial consultation to closing.Key Responsibilities:Analyze financial information and assess creditworthiness to determine the...

  • Tax Manager

    4 weeks ago

    Indianapolis, Indiana, United States Cherry Bekaert Advisory, LLC Full time

    Job OverviewCherry Bekaert Advisory, LLC is seeking a highly skilled Tax Manager to join our Core Tax Services team. As a key member of our team, you will be responsible for overseeing the preparation and review of complex tax returns, tax provisions, and related compliance matters for our insurance industry clients.This is a leadership role that requires a...

  • Professional RN

    3 weeks ago

    Indianapolis, Indiana, United States TotalMed Staffing Full time

    About This RoleAs a Medical Surgical Telemetry Registered Nurse with TotalMed Staffing, you will provide specialized care in acute care settings. Responsibilities include assessing, planning, and implementing patient care, collaborating with the Medical Surgical Telemetry Registered Nurse team, and ensuring quality care delivery.Job Details$2,080.12 /...