91 Medical Industry jobs in the United States

Summary:

We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You will work on cutting-edge wearable technologies, including augmented reality glasses, wrist wearables, and other innovative devices.

Required Skills:

Medical Devices, Regulatory Specialist Responsibilities:

1. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager

2. Support regulatory compliance activities, including site registration, audits, post-market vigilance reporting, product recalls, etc., as needed

3. Prepare FDA, European and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed

4. Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions

Minimum Qualifications:

Minimum Qualifications:

1. Bachelor's degree in a scientific discipline or equivalent work experience

2. 3+ years of industry experience in medical device regulatory affairs or related industry

3. Experience working with minimal supervision and under general direction only

4. Experience multitasking, supporting multiple projects, functioning on a global basis, prioritizing, conducting team meetings, and meeting project deadlines

Preferred Qualifications:

Preferred Qualifications:

1. Experience with Food and Drug Administration requirements, guidance documents, Active Medical Device Directive/EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

2. Advanced degree in a scientific discipline (engineering, physical/biological or health sciences) or in Regulatory Affairs

3. Regulatory Affairs Professionals Society Regulatory Affairs Certification

4. Demonstrated experience in negotiation skills, authoring technical reports and submissions, and presenting to cross functional peers and leadership

Public Compensation:

$90,000/year to $137,000/year + bonus + equity + benefits

Industry: Internet

Equal Opportunity:

Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.

Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at

About the job Project Manager, Medical Devices

The Project Lead is responsible for providing cross-functional program leadership to ensure projects achieve desired outcomes from product definition through product commercialization.

This leader will help teams define and achieve the objectives and goals required to complete projects on time and within budget. Their focus will be on driving high levels of collaboration and execution across teams. They will ensure effective management of portfolios with a focus on effective design control and risk taking. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.

Responsibilities:

• Provide cross-functional program leadership to drive strategic growth initiatives, innovation portfolio and programs.
• Establish, maintain, and influence program stakeholder relationships, expectations, and communications, both internal and external to the organization.
• Present data and recommend program improvements to senior leaders.
• Execute program plans (quality, risk, communication, staffing, etc.) and capture and communicate program status and data in order to maintain accurate and current program information for the use of stakeholders.
• Originate and drive Project Management Office (PMO) continuous improvement activities. Optimize resource allocation of portfolio in partnership with functional leaders across divisions/site.
• Track overall program progress and provide detailed management status reports. Ensure projects are run in compliance with company, FDA, and ISO procedures.
• Oversee and provide guidance across all phases of the product development life-cycle process from concept to commercialization.
• Drive organizational and program learnings/best practices to continually improve organization to best in class PMO.
• Establish best practices across the company for project management.

• Bachelors Degree required. Masters Degree and/or MBA preferred.
• Program Management Professional (PgMP) or Portfolio Management Professional (PfMP) certification preferred.
• M&A integration experience highly desired.
• 2+ years of experience in the medical device industry.
• 2+ years of experience in a project management role or equivalent experience.
• Experience with project management tools such as MS Project or other.
• Excellent interpersonal skills in addition to having the ability to effectively communicate within the project teams as well as to top level management
• Collaborative leader who excels in leading through ambiguity
• Ability and experience with communicating effectively with executive leaders.
• MS Project software experience
• Understanding ISO and FDA guidelines as they apply to Product Development
• Excellent organization and time management/multi-tasking skills (comfortable in an ambiguous and fast-paced environment, operating at both strategic and tactical levels)

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This range is provided by VIVOS Professional Services, LLC. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.

$60.00/hr - $5.00/hr

Direct message the job poster from VIVOS Professional Services, LLC

Mallinckrodt Pharmaceuticals is an international Pharmaceuticals and Medical Device manufacturer that has been managing complexity and improving lives since 1887 and distributing high quality drug delivery systems since early 2000. We offer a rewarding work environment with global opportunities while maintaining an employee-focused atmosphere. We are currently searching for a dynamic Technical Project Manager to join our Device Engineering and Operations team in Madison, WI.

Reporting to the Director of Engineering, the Technical Project Manager will be an engineering professional, responsible for leading technical projects through planning, scheduling, budget management, resource management for change control and stage gate projects in alignment with the department's SOPs in a matrix of cross functional groups. Leads and delivers projects as a project management expert. Will be responsible for project planning and management along with all activities needed for product development projects in accordance with design controls. Follows operating mechanisms for monitoring project progress and for intervention and problem solving through collaboration with other technical team members. Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost. Integrates with the project teams and facilitates discussions on technical and nontechnical problems throughout the life of the project. Oversees and coordinates work performed by outside contractors. Provides timely and accurate information and status updates to project stakeholders and management. Participates in budget development and evaluating how project plan changes impact cost, resource requirements and schedule.

• Project Management Lead and manage multiple sustaining engineering and fixture development projects, encompassing both hardware and software, from initiation through closure.
• Leads risk assessment for technical and project related issues and developing mitigation plans to ensure appropriate mitigations are in place, to ensure schedule and costs are maintained.
• Develop and maintain detailed project plans, timelines, budgets, and resource allocations. Tracks and manages project budgets, metrics, and resource utilization
• Facilitate regular project meetings, track progress, and manage risks and issues.
• Report out progress, issues and status at regular review meetings.
• Ensure projects meet regulatory, quality, and business requirements.
• Manages multiple concurrent projects and ensures timely progress reporting and escalation of issues impacting deliver
• Cross-Functional Leadership Collaborate with Product Development, Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Coordinate with external vendors and contract manufacturers as needed.
• Serve as the primary point of contact for project status and communication.
• Sustaining Engineering Manage engineering change orders, product updates, and obsolescence strategies.
• Support root cause analysis and corrective/preventive actions (CAPA).
• Drive cost reduction, reliability improvements, and design optimizations.
• Manufacturing Fixture Development Oversee the design, validation, and implementation of manufacturing fixtures and tooling.
• Ensure fixtures meet any ergonomic, safety, and regulatory standards.
• Support process validation (IQ/OQ/PQ) and documentation.

Job Requirements:

• Education & Experience Bachelor's degree in Engineering, Biomedical Engineering, Computer Science, Mechanical Engineering, or related field.
• 3+ years of project management experience in the medical device industry.
• Experience with sustaining engineering and manufacturing support is a plus
• Strong knowledge of FDA 21 CFR Parts 820, design controls, ISO 13485, and GMP.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira).
• Excellent communication, leadership, and organizational skills.
• PMP certification or equivalent is a plus.
• Familiarity with CAD tools and fixture design principles is a plus.

• Seniority level Mid-Senior level

• Employment type Contract

• Job function Project Management
• Industries Medical Equipment Manufacturing

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Job Description

Role: .Net Architect with Medical Devices
Domain EXP: (Healthcare Domain/ Medical Device Companies)
Location: Merrimack, NH (Onsite Day one)
Duration: 6 Months
Experience Needed: 12+ Years

Job Description

Architect:

Architect and develop software systems for medical devices in compliance with IEC 62304.

Design scalable solutions using C# .Net Core 8 and Service-Oriented Architecture (SOA) and microservices.

Implement communication protocols with gRPC (Google Protocol Buffers) in SOA.

Develop state machines for managing system workflows and behaviors.

Optimize system performance and ensure design and architectural best practices.

Create and maintain technical documentation, including architecture diagrams and specifications

Follow Software development lifecycle (SDLC) processes, including version control, CI/CD pipelines, and automated testing

Coordination with Customer stakeholder and contribute to design discussions

Educate offshore team with the decisions, review their work and communicate with customer

Thanks & Regards,

Qualifications:
Additional Information

All your information will be kept confidential according to EEO guidelines.

Premier IP Boutique Firm with Cravath level compensation.
Among the leaders in every category of Patent Law and PTAB Activity.
The firm provides meaningful responsibility to new lawyers, and a realistic path to Partner.
Awarded "Outstanding Workplace Award" for a positive and healthy firm culture.
Represent primarily mid-sized to large companies.

REQUIREMENTS
• Degree in biomedical engineering, mechanical engineering, physics or related field and experience with medical devices.
• Prior patent prosecution experience.
• Active membership in the state bar and compliance with CLE requirements.
• Registration before the U.S. Patent and Trademark Office.
• Superior writing skills and excellent academic credentials.
• Ability to thrive when using your analytical skills to conduct complex and detailed analysis of legal matters.
• Enjoy communicating with a diverse group of clients, attorneys, and staff.
• Enthusiastic about working within a team-oriented environment and will contribute to effective team relationships.

SUMMARY
Vanguard Intellectual Partners (Vanguard-IP) specializes in the placement of IP/Patent professionals nationwide.

Our concentrated focus in these areas enables us to more deeply understand our clients' technical needs, and our candidates' individual talents and career interests. Our broad network of long-term client relationships gives us a competitive edge.

Our recruiters all have 10+ years of IP recruiting experience, and an exceptional record of success. We have superior knowledge of the IP job market, and offer trusted career advice for our candidates. We also have the resources and high-level contacts to get your resume noticed by the people who matter.

We look forward to speaking with you, and learning more about what you are seeking in your next opportunity.

CONFIDENTIALITY
At Vanguard-IP, we respect the confidentiality of every candidate who contacts us. Furthermore, we will always obtain expressed authorization before submitting your resume to any of our clients.

**Should you have an interest in exploring opportunities in another location, we have hundreds of openings in other markets. Please apply now and our team would be happy to review your information for this or other openings in your location of interest.