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Seniority Level: Mid-level
Industry: Medical Device / IVD
Employment Type: Employee
Location: Remote (US based)
Travel: Yes, candidate must have the desire and ability to travel

Duties and Responsibilities

• Work with clients to develop IEC 62304 complaint documentation (all software classifications).
• Design History File audits for compliance to IEC 62304.
• Leading and mentoring Agile and Scrum software teams:
• Development Lifecycle Planning
• Requirement Development
• Hazard Analysis
• Cyber Security Threat Modeling
• Anomaly Analysis
• Verification documentation methods
• Automated testing
• Cybersecurity implementation development, including post-market Vulnerability Monitoring.

Skills and Qualifications

• Bachelor’s degree in Engineering or in a closely related / equivalent field.
• Minimum five years of experience in the software quality environment within the Medical Device industry.
• Proven hands-on experience with implementation of IEC 62304.
• Knowledge of Bluetooth, IoT, and mobile devices
• Working knowledge of ISO 14971, Part 11, Human Factors, ISO 13485, FDA Quality System Regulation, and EU MDR.
• Hands-on ability to work autonomously to problem-solve
• Excellent communication, time management, and analytical skills required.
• Experience with small / startup company desired.
• Electromechanical experience a plus, including knowledge of IEC 60601.

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Seniority Level: Mid-level
Industry: Medical Device / IVD / Biotech
Employment Type: Employee
Location: Remote (US based)
Travel: Yes (~5%)

Hands-on role supporting the Director of Regulatory Services with the growth of the Regulatory side of the business. A self-starter and a multi-tasker, this position will work on multiple exciting projects in tandem, mostly with limited supervision. While strong regulatory expertise is a must, time management and communication are equally as important.

Duties and Responsibilities (will be variable depending on the nature of the client projects to be undertaken)

• Work with clients to determine the classification and regulatory pathway for US, EU, and other international markets.
• Manage multiple, parallel projects to successful completion.
• Strategize, develop, prepare and submit 510(k)s, Non-filling justifications (Letters to File), Pre-Submission meeting requests, Premarket Authorizations (PMA), Technical Files, Investigational Device Exemptions (IDEs), de novo reclassification requests, 513(g) requests for classification, and Clinical Evaluation Reports.
• Liaise with Regulatory bodies (FDA, EU, UK, Health Canada, etc.) on product submissions.
• Evaluate and troubleshoot client-prepared regulatory documentation.
• Labeling / advertising / promotional material assessment.
• Act as embedded Regulatory team member for clients, including design and process change reviews, Design Reviews, labeling reviews, field action decisions, CAPA representation.

Skills and Qualifications

• Bachelor’s degree (or equivalent experience), preferably in a Scientific or Technical discipline.
• Minimum of ten years of related regulatory experience, including:
  – Regulatory position with a small or start-up company.
  – Preparing and submitting 510(k)s in the past two years.
  – Preparing CERs and Technical Files in the past two years.
  – Requesting Q or Pre-Submissions to FDA and participating in FDA meetings.
  – Demonstrated knowledge of Regulatory plans for Design Control projects, participation as a Regulatory team member in Change Control processes, Regulatory strategies for early-stage innovations.
• Knowledge and documented training to EU MDR and FDA regulations required. Canada, China, Brazil, Japan, India, Middle East, and Australia a plus.
• Experience with PMAs a plus.
• RAC certification a plus.
• IVD and CLIA certification a plus.
• Previous consulting and clientele relationship experience a plus.
• Must possess excellent verbal, time management, and written communications skills
• Proven history of presentation, organizational, and project management skills.
• Experience with Microsoft Word, Excel, PowerPoint, and Outlook required.

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Seniority Level: Associate
Industry: Medical Device / IVD / Biotech
Employment Type: Employee
Location: Remote (must be US-based)
Travel: Yes. Must have the ability and desire to travel.

Position description:
Hands-on role supporting the Director of Regulatory. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem. While strong regulatory expertise is a must, time management and communication are equally important.

Duties and Responsibilities: (will be variable depending on the nature of the client projects)

• Work with clients to determine the appropriate product classification and risk category resulting in a recommended regulatory pathway within the US, EU, and other international markets.
• Write Regulatory Strategy Plans.
• Manage multiple, parallel projects to successful completion.
• Prepare, organize, and submit product submissions to third party regulators (510(k), PMA, Technical Files).
• Prepare Non-filling regulatory justifications.
• Collate and prepare Clinical Evaluation Reports, product State of the Art Reviews, and Post Market Surveillance reports.
• Assist clients with product registration and Canadian License Applications.
• Liaise with Regulatory bodies (FDA, EU, UK, Health Canada, etc.) on product submissions.
• Evaluate client-prepared regulatory documentation.
• Assess labeling, advertising, and promotional material for compliance with applicable standards and symbols.

Skills and Qualifications:

• Bachelor’s degree (or equivalent experience) in a Scientific or Technical discipline.
• Minimum three to five years of related regulatory experience, including:
  – A regulatory position with a small or start-up company.
  – Writing and submitting at least two 510(k)s in the past two years.
  – A major contributor to at least one CER submission in the past two years.
  – Q or Pre-Submissions into the FDA and FDA meetings.
• Knowledge and documented training to EU MDR and FDA regulations. Canada, Japan, China, and Australia a plus.
• Excellent communication and time management skills are required.
• Experience with deNovo, PMAs, and/or Technical Files desired.
• RAC certification a plus.
• Unique Device Identifier experience a plus.
• FDA eMDR experience a plus.

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Seniority Level: Associate
Industry: Medical Device / IVD / Biotech
Employment Type: Contract
Location: Remote (must be US based)
Travel: Yes, candidate must have the desire and ability to travel

Position description:
Hands-on role supporting the Vice President of Quality Systems. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem. While strong quality expertise in the medical device industry is a must, time management and communication are equally as important.

Duties and Responsibilities: (will be variable depending on the nature of the client projects)

• Quality system development and implementation, including writing / reviewing procedures, for clients of all sizes.
• Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, and MDSAP audits.
• Deliver customized client training and education programs on Quality Management Systems and other industry topics.
• Potentially serve as client adjunct quality staffing.
• Propose and develop client corrective action strategies and plans.
• Assist Clients with logistics, gap assessment, and preparation for Notified Body assessments and FDA inspections.
• Ensure client deliverables are well organized, relevant, complete and compliant to regulations and the client’s internal procedures/formats.
• Use email communication and electronic database entries judiciously.

Skills and Qualifications:

• Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
• Minimum four years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device manufacturing industry. Experience to include:
  – Quality auditing experience to ensure compliance with ISO and FDA regulations.
  – Implementing corrective and preventative action to address compliance issues.
  – Participation in FDA inspections.
• Working knowledge and documented training to ISO 13485:2016, 21CFR 820 Quality System Regulation, and EU MDR. EU IVDR experience a plus.
• Proven hands-on experience with document management, training, CAPA, management review, risk management, and quality improvement initiatives.
• Excellent communication and time management skills required.
• Lead Auditor certification a plus.
• Software experience a plus, including knowledge of ISO 62304.
• Usability experience a plus, including knowledge of ISO 62366.
• Electromechanical experience a plus, including knowledge of ISO 60601

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Seniority Level: Associate
Industry: Medical Device / IVD / Biotech
Employment Type: Employee
Location: Remote (US based)
Travel: Yes 

MEDIcept is looking for candidates for our “consultant trainee” program. This is not an internship, but a multi-year commitment. In this position, you will become a Subject Matter Expert in one of the three regulated disciplines noted below by: 

• Enrolling and successfully completing the MEDIcept professional development training program, consisting of three months of internal training
• Completing three rotations (3 months each) of understudy on a MEDIcept client project, overseen by the SME in the areas of Regulatory, Clinical, and Quality Services.
• Obtaining and maintaining a professional certification in the discipline of interest as mentioned above. 

Responsibilities

• Provide input and solutions to internal practices, programs to advance MEDIcept as a leader in the in the industry.
• Adhere to company timekeeping and expense policies and ensure project external consultant are training and follow them as well.
• Deliver customized client training and education programs.
• Lead adjunct staffing project with MEDIcept temporary consults, ensuring completion and effective project goals.
• Assist with development and expansion of MEDIcept services, maintaining general knowledge in current regulatory, quality, clinical affairs, and business practices.
• Identify client-regulated processes that may require improvement, correction, or additional contracted resources.
• Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
• Draft proposals and time costing where business opportunities are identified.
• Determine project measures of success, in quality, delivery time, and costs.
• Develop strong relationships with clients, providing timely and accurate communications.
• Resolve concerns, issues, and conflicts to ensure Client expectations are met, and project deviations are agreed upon and understood.
• Assist with time study, project costs and reporting on project deliverables.
• Agree to a minimum of three (3) years contract. 

Skills and Qualifications 

Minimum of 2 years relatable experience in a medical device, biotech, IVD, or related industry such as:
1. Experience monitoring and maintaining quality management systems, or
2. Creating regulatory filings/submissions, or
3. Participating in medical device clinical studies, or
4. Participating in Post-market surveillance, complaint management, or
5. Project manager for device design and development of Design History File. 

• Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or a closely related/equivalent field.
• Working knowledge of ISO 13485, FDA regulations for medical devices, and EU MDR/IVDR requirements.
• Project Management skills desired.
• Excellent communication and time management skills required to interact with all management and associates levels.
• Excellent organizational skills with the ability to manage across multiple projects.
• Proficient in MS Office applications.
• Working knowledge of an industry database software application such as Arena, TrackWise, QT9, Seapine, MasterControl, etc.

Soft Skills 

• Comfortable in new situations and environments.
• Adept at managing changing priorities, direction, and dissent.
• Ability and willingness to prepare and present technical topics to an audience.
• Understanding of other perspectives/personality/views.

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