Join Our Team

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

Technical, hands-on role to support our rapidly expanding Regulatory team. Using their design assurance and regulatory experience, this position will assist our clients as they develop their devices in readiness for product approvals and clearances while ensuring a high degree of technical capability of their regulatory submissions. A self-starter and a multi-tasker, this individual will work on multiple exciting projects in tandem, with limited supervision. While regulatory, design, and risk management experience in the medical device industry are strong must-haves, time management and communication are equally important. 

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

• Work with clients to create Design and Risk Management documentation for devices being developed for product marketing submissions. May also be required to evaluate product design documentation to meet various regulatory expectations.
• Creation and execution of Regulatory Strategies and Plans for medical devices and in vitro diagnostics in the US and international markets, including assessing regulatory impact of changes to design, materials, labeling, sterility, software, and suppliers.
• Develop the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released.
• Participate in the development of US and international product clearance and approval submissions.
• Manage multiple, parallel projects to successful completion.
• Act as embedded Regulatory team member for clients, including design and process change impact assessments, Design Reviews, labeling reviews, field action decisions, and CAPA representation.

Skills and Qualifications  

• Bachelor’s degree (or equivalent experience), preferably in an Engineering discipline.
• Minimum 5 years of medical device product design documentation experience.
• Proven ability to apply Design and Risk Management requirements across a wide variety of medical devices and in vitro diagnostics.
• Experience with contributing to medical device product clearance or approval submissions such as 510(k), de novo, PMA, international documents or registration, labelling, and marketing of medical device worldwide.
• Familiarity with medical device regulations (21CFR), MDR/IVDR, and other international medical device requirements.
• Experience with medical device performance standards and test methodologies such as IEC60601-1, IEC61010, ISO 10993, ASTM 4149, and ISTA.
• 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.
• RAC certification a plus.
• Previous consulting and clientele relationship experience a plus.

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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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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: 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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