Regulatory Affairs Specialist
LanceSoft
Description: Responsible for assisting the team with regulatory filings as necessary to market Client products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process. Duties:
- Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.
- Respond to requests from foreign government and/or distributors as needed
- Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
- Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
- Evaluate risk of proposed regulatory strategies; may offer solutions
- Reviews proposed labeling for compliance with applicable global regulations
- Writes and manages the development of package inserts
- Reviews and evaluations promotion and advertising material for compliance with applicable regulations
- Reviews proposed product changes for impact on regulatory status of the product
- Communicates with regulatory and governmental agencies with supervision
- Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams
- Strong writing, communication, and interpersonal skills
- Strong attention to detail; ability to multi-task and balance competing priorities
- Knowledge of overall business environment, the orthopaedic industry, and the marketplace
- Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
- Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
- Knowledge of FDA, EU, and other regulatory body regulations
- Ability to identify risk in Regulatory strategies
- Strong problem solving skills
- Effective negotiating skills
- Basic computer skills, including Microsoft Office Suite
- Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
- A minimum of one year of experience in orthopaedic or medical device industry preferred
- A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
- Regulatory Affairs Certification (US or EU) preferred
- A combination of education and experience may be considered
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Specialist in Warsaw, IN vacancy
- At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeWe are seeking...SuggestedFull timeFlexible hours
- Managing Director | WealthBridge WealthBridge Financial Group is seeking a proven financial advisor for a strategic Managing Director . This role is ideal for an experienced advisor who has successfully built a personal practice and is now ready to take on a leadership...SuggestedVisa sponsorship
WealthBridge Financial Group
Warsaw, IN1 day ago - Group Objectives The leadership board assists with the completion of launch steps 8-10 and operation of the live program by: Providing input and direction to the program director as he/she manages the day-to-day operations of the program Assisting with the...SuggestedLocal area
LifeWise Academy
Warsaw, IN4 days ago - ...stakeholders.Ensure that IT projects are delivered on time, within the approved budget, and in compliance with quality, security, and regulatory requirements.Stakeholder Engagement and Relationship Management:Build and maintain effective working relationships with business...SuggestedNight shiftWeekend work
US Tech Solutions
Warsaw, IN3 days ago - ...stakeholders.Ensure that IT projects are delivered on time, within the approved budget, and in compliance with quality, security, and regulatory requirements.Build and maintain effective working relationships with business and IT stakeholders.Provide clear, concise status...Suggested
ICONMA
Warsaw, IN3 days ago $79k - $142k
...to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion...Full timeContract workLocal areaImmediate startRemote work$79k - $127.65k
...to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion...Full timeTemporary workWork at officeLocal areaImmediate startRemote work- Job Title : SEAL Officer Category / Component : Officer • Both Overview Naval Special Warfare Key Responsibilities SEAL Officers lead small, elite teams in maritime special operations worldwide, conducting high risk missions from sea, air, and land in support of national...Part timeApprenticeshipWorldwide
US Navy
Warsaw, IN5 hours ago - ...inventory management, risk assessments, policy compliance tracking, regulatory monitoring, and stakeholder reporting. The Sr Analyst works... ...recommendations Coordinate with Quality and Regulatory Affairs teams to ensure AI governance processes complement, rather...Remote work
Varite
Warsaw, IN1 day ago - Job Title: AI Governance Sr Analyst Job ID: 37500470 Duration: 12 Months Location: Warsaw, IN Key Responsibilities: Manage AI asset inventory and lifecycle. Coordinate AI governance intake, approvals, and risk assessments. Track compliance with EU AI...
Artech
Warsaw, IN4 days ago $122k - $212.75k
...to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion...Full time- DescriptionDentons Business Services EMEA is the operational backbone of Dentons across Europe, the Middle East and Africa. As part of the world’s largest global law firm, our business services teams support legal professionals and business teams across multiple jurisdictions...Full timeLocal area
- ...Description:DePuy Synthes is recruiting for a CQ Specialist QMS/Compliants, located in Warsaw Poland... ...role directly supports patient safety, regulatory compliance, and continuous improvement... ...Manufacturing, R&D, Regulatory Affairs, and Customer Service, to support quality...Full timeLocal area
$26.04 - $27.31 per hour
...Community Support Specialist - Youth Department: Youth CPRC Employment Type: Full Time Location: Warsaw Compensation: $26.04 - $27.31 / hour Description Empower Youth and Families as a Community Support Specialist Make a difference where it matters most - in the lives...Full timeWork experience placementFlexible hoursWeekend workAfternoon shiftCompass Health Network
Warsaw, IN3 days ago$150k - $300k
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise...Full timeImmediate start- ...PolandJob Description:DePuy Synthes is recruiting for a CQ Specialist DC PL, located in Warsaw, Poland.Job Overview The CQ Specialist... ...products in Poland. This position supports Quality & Regulatory Affairs (QARA) International by maintaining and improving quality processes...Full timeWork experience placementLocal area
- The Chief of Staff is a senior strategic leadership role designed to extend the reach, effectiveness, and executional capacity of the Group CEO. Acting as a high-level strategic partner, this role ensures that the CEO’s priorities are translated into measurable outcomes...Work at office
Henley & Partners - The Firm of Global Citizens®
Warsaw, IN1 day ago - Job Description Job Description Shipping & Office Coordinator Warsaw, IN| 20-22hr. | Day shift with possible overtime We are looking for an organized, self-motivated and detail-oriented Shipping & Office Coordinator to create work orders and scheduling of items...Work at officeLocal areaDay shift
Zing! Recruiting
Warsaw, IN10 days ago $120k - $180k
...teams, and the PMO organization, ensuring projects are delivered on schedule, within budget, and in compliance with quality and regulatory requirements. The successful candidate will drive measurable business and operational outcomes while fostering collaboration and...Full timeH1bWork at officeLocal areaImmediate startFlexible hours$75k
Job Description Ready to jump-start your career and take charge of your earning potential? At Platinum Supplemental Insurance, we’re looking for motivated individuals ready to learn, grow, and thrive in a fast-paced environment. Whether you’re a recent grad or simply...Flexible hoursNight shiftPlatinum Supplemental Insurance
Warsaw, IN2 days ago- ...applications. Experience leading cross-functional, inter-site project teams with results-oriented performance. Strong knowledge of regulatory environments, preferably in medical device or similar industries. What's in it for you? Competitive compensation package...Temporary work
IDR
Warsaw, IN5 days ago - ...adherence to project budget, tracking of relevant project metrics, achievement of expected outcomes, adherence to quality assurance and regulatory compliance requirements, creation of technical documentation, execution of testing activities, and the design and management of...
Fusion Life Sciences
Warsaw, IN2 days ago $42.9k
Work for Indiana Begin a fulfilling career with the State of Indiana by joining one of the largest employers in the state, offering a range of opportunities across 60+ agencies. At the state, you'll find competitive compensation, a robust benefits package and ...Full timeApprenticeshipWork experience placementWork at officeRelocationState of Indiana
Warsaw, IN8 days ago- Financial Analyst At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds...Remote workFlexible hours
Zimmer Biomet
Warsaw, IN2 days ago $44.67 per hour
...and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should... ...67/hr We are searching for the best talent for Maintenance Specialist JOB SUMMARY Will perform maintenance on all mechanical and...Hourly payApprenticeshipLocal areaJ&J Family of Companies
Warsaw, IN1 day ago$21.63 per hour
Pay: $21.63 per hour Hours: 40 hours per week, with some nights and weekends Job Description: Support: Assist adults with disabilities in their jobs and career planning. Career Development: Provide on-the-job training and assessment and foster positive workplace relationships...Hourly payLocal areaNight shiftWeekend workCardinal Services Inc of Indiana
Warsaw, IN3 days ago- ...Insight Global’s Med Tech client is looking for a Product Support specialist to assist external customers (patients) and internal sales... ...other CRM systems (huge plus) • Previous experience in hospital administration, tech support, medical device or regulatory environment...
Insight Global
Warsaw, IN2 days ago - DescriptionIntroductionDentons Business Services EMEA is the operational backbone of Dentons, supporting the world's largest law firm in delivering exceptional service to clients across Europe, the Middle East, and Africa. As a crucial component of Dentons' global network...Full timeWork at officeFlexible hours
- ...with meaningful budget responsibilityExperience in a dedicated client service or embedded legal ops roles.Exposure to cross-border regulatory, M&A, or commercial matters.Working knowledge of legal AI platforms such as Harvey, Legora, or comparable tools.Key...Work at officeLocal area
$79k - $142k
...practices throughout the product lifecycle. The Exp, Analyst, Security Engineer Product partners closely with engineering, quality, regulatory, and IT teams to identify risks early, design secure solutions, and ensure products meet cybersecurity and regulatory...Full timeLocal areaImmediate start
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist. Be the first to apply!
