Onsite Position Located in MA

The Senior Compliance Engineer will ensure products comply with standards and regulatory requirements (Safety, EMC, EMI) in worldwide markets.

Responsibilities:

• Monitor the status of relevant international standards and provide guidance on present and future regulatory testing requirements.
• Support pre-compliance testing and mitigation of new and modified designs.
• Interact with third-party test houses that conduct compliance testing. This includes the creation of EMC test plans, checklists, documentation packages, on-site test support, test report reviews.
• Support risk analysis activities, including risk management plans, hazard analysis, FMEA, and risk management reports.
• Assist regulatory department with FDA, CE, and other regulatory submissions.

Requirements:

• Bachelor's Degree in scientific or engineering field; electrical engineering is preferred.
• 10+ years of experience with development and compliance testing of Class II electro-mechanical medical devices.
• Knowledge of standards and regulations such as ISO 14971, IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-22, 60825-1, 62366, 62304, ETSI EN 301 489, 21 CFR 1040.10, 1040.11
• Knowledge of Design Controls, regulations, and standards such as FDA QSR's and ISO 13485 is preferred.
• Knowledge of EMC/EMI mitigation techniques is preferred.
• Supporting medical device compliance testing (e.g. EMC, EMI, and Safety) with external test houses, such as TUV and Intertek, including EMC Test Plans, Safety Checklists, and documentation packages.
• Knowledge of technical design and risk management documentation, including design specifications, verification/validation protocols, risk management plans, hazard analysis, FMEA, and risk management reports.
• Demonstrated capability to work on multiple programs on cross-functional program teams and be an expert relative to product standards and regulatory requirements.
• Experience with lasers and optical technologies is preferred but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

#medicaldevice #complianceenginner #classII #electromechanical #emc #emi #testhouses #iso #iec #newjobalert

Onsite Position Located in MA

My client seeks a Design Assurance Engineer for Class II electro-mechanical medical devices. In this role, you will ensure that the products meet regulatory and quality requirements throughout the design and development process. This involves collaborating with cross-functional teams to verify and validate the design outputs against user needs and regulatory requirements.

Responsibilities:

• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support Design Engineering in the creation of Design History and Technical Files.
• Interact with third-party test houses that conduct compliance testing of IPG products.
• Assist the regulatory department with FDA, CE, and other regulatory submissions.
• Perform all other essential duties as assigned.

Requirements:

• Bachelor's Degree in scientific or engineering field; electrical engineering is preferred.
• 2-5 years of experience with engineering and development of Medical Devices,
• Class II electro-mechanical medical devices experience preferred.
• Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSR's, ISO 13485, ISO 14971, 60825, 62366, and 62304, is preferred.
• Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV and Intertek.
• Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.

• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power, and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred.
• Experience with lasers and optical technologies desired but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

#medicaldevice #electromechanical #designassurance #devicehistory #qualityassurance #classII #lasers #newposition #electro-mechanical

Our client is a commercial-stage medical device company dedicated to improving patient outcomes through innovative products. With a focus on excellence and quality, they are at the forefront of the medical device industry, delivering cutting-edge solutions to healthcare providers globally.

Position Overview: We are seeking a highly skilled and experienced Senior Director of Operations to join our client's dynamic team. In this key leadership role, you will oversee and optimize the manufacturing programs, ensuring the highest operational efficiency and compliance with regulatory requirements. You will lead a team of Operations Managers, fostering a culture of collaboration and continuous improvement to drive the success of our manufacturing operations.

Responsibilities:

• Achieves local, onsite operational goals, including productivity, quality, cost, delivery, safety, and colleague engagement requirements while strictly adhering to FDA and other government and local regulations.
• Responsible for oversight of the Operations Managers and their teams.
• Oversees the external manufacturing, servicing, maintenance, and distribution of class II medical device products, ensuring consistently meeting safety, production, performance, and quality standards.
• Review operations, servicing, maintenance, and distribution reports to ensure safety, quality, financial, and delivery goals and standards are met.
• Develop and implement a risk-based oversight program for all outsourced manufacturing, servicing, and maintenance operations to ensure full compliance with FDA regulations.
• Ensures the proper operational controls, metrics, procedures, and personnel are in place to grow the organization for financial and operational efficiencies effectively.
• Stay abreast of industry trends and best practices in operations management.
• Assists VPs of Engineering, Sales, and Finance with long-range operating goals, expansion efforts, and new and advanced technology/product implementation.
• Develop and execute strategies to maximize production efficiency, reduce waste, and improve overall operational performance.
• Monitor key performance indicators (KPIs) such as CFR, on-time shipment, cycle times etc.; implement corrective actions as necessary to achieve operations goals.
• Lead and support lean manufacturing initiatives, process improvement projects, and the implementation of new technologies to enhance productivity.
• Foster a culture of innovation and creativity in problem-solving.
• Works with the Finance Team to develop an operating budget and ensure cost controls in the manufacturing process.
• Delivers progress and production reports to executive team members as requested.
• Supervises equipment purchase, maintenance, and layout.

Requirements:

• Experience in the medical device industry is required.
• Bachelor’s degree in Manufacturing, Engineering, Business, or a related field (Master's degree preferred).
• Proven experience in manufacturing leadership roles, with at least 10 years of experience in a similar position
• Proven track record of success in leading and optimizing operations at a senior level.
• In-depth knowledge of key supply chain/logistics processes and best practices.
• Knowledge of Quality Control, Manufacturing Engineering, Purchasing, Planning, Inventory Control, Document Control, Shipping and Receiving, Facilities and maintenance, FDA GMP, and ISO 13485 regulations.
• Strong understanding of manufacturing processes, quality management, and continuous improvement methodologies (e.g., Lean, Six Sigma).
• Excellent leadership, team building, and communication skills.

#medicaldevice #medicaldevicemanufacturing #operations #seniordiredctor #supplychain #quality #leadership #fda #newposition #executivesearch

My client seeks a highly motivated Director of Regulatory Affairs to join their growing organization. In this role, you will be responsible for all activities to lead and maintain global regulatory approvals to market devices throughout the product development lifecycle while building and managing a regulatory team.

Position located in MA. Must be in MA or willing to relocate.

Responsibilities:

• Develop strategies for regulatory approval of medical devices worldwide based on business needs.
• Organize project teams, initiate project schedules, and provide project leadership worldwide to achieve desired regulatory outcomes within defined timeframes.
• Prepare global regulatory applications, including US medical submissions (pre-submissions, 510ks, IDEs, and annual reports) and EU MDR, and design dossiers and technical files for other international markets.
• Interact with the US FDA and other regulatory authorities worldwide.
• Manage reporting to the FDA (MDRs) and Vigilance Reports; participate in the Complaint System.
• Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
• Participate in Risk Management assessments.
• Review design and manufacturing changes for compliance with applicable regulations.
• Oversee and prepare documentation to support the Clinical Evaluation Report to ensure accuracy, applicability, consistency, and control of regulatory documents.
• Support quality system audits by notified bodies, government agencies, and customers.
• Assist with environmental regulations and standards (e.g., RoHS, REACH, etc.).
• Hire, mentor, and train regulatory staff; engage outside contractors as needed.
• Perform all other essential duties as assigned.

Requirements:

• Must have experience with programmable electro-mechanical and sterile medical devices.
• Bachelor's degree, preferably in an engineering or life sciences discipline, advanced degree preferred.
• 10+ years of regulatory experience with US and international submissions.
• Demonstrated aptitude for preparing and submitting 510(k)'s and international design dossiers for new products.
• Medical Laser experience preferred.
• Prior interaction with the FDA and other worldwide agencies is required.
• Hands-on knowledge of all phases of Design Controls and Risk Management practices, regulations and standards, including FDA QSR's, ISO 13485, 14971, 10993, 11607, 14644, 14698, 15223, 11135, 11138, 11737, 17665, and 22442, and IEC 60601, 60825, 62304, and 62366.
• Experience in building and managing regulatory teams and leading cross-functional project teams on collaborative projects.
• Strong working knowledge of Microsoft Word and Excel.

#medicaldevice #regulatorystrategy #director #medicallaser #electromechanical #newposition #steriledevices #classII #electro-mechanical #npd

Location - Hybrid Position Greater Boston

Our client is a commercial-stage pharmaceutical company committed to developing and commercializing therapeutics to help improve patients' lives with severe eye disorders. With approved products and a robust pipeline, this is the perfect time to join this growing team.

Overview: In this high visibility role, you will report directly to the Chief Regulatory Officer. The Director of Regulatory Affairs Strategy will be responsible, in alignment with the CRO, for assisting in designing regulatory strategies during the development and life-cycle management of assigned programs. In this role, you will act as the primary regulatory liaison with the US FDA and work closely with the Global Clinical Research Organization and ex-US consulting firms to coordinate the execution of established regulatory submission plans.

Responsibilities:

• Assists the Chief Regulatory Officer (CRO) in designing and implementing regulatory strategy plans for assigned products/projects, form development, and throughout the life cycle of the dossier/product.
• Working closely and collaboratively with Regulatory Operations and Regulatory CMC, this is a 'hands-on' position where an individual must be versatile and capable of managing the operational workload and strategy execution.
• Interfaces directly with the US FDA and acts as primary liaison.
• Authoring health authority responses alongside subject matter experts and submission deliverables.
• Manage the routine maintenance of open regulatory applications, emphasizing high-quality, timely submissions to Regulatory Agencies, submission activities initial IND, NDA.
• Coordinates with Regulatory Operations and Regulatory CMC.
• Works closely with CRO to prepare and facilitate informal and formal regulatory meetings aligned with established regulatory and development strategies.
• Participates actively and assists CRO in the Advertising and Promotional Review and submission (FDA 2253) process.
• Works with functional groups to ensure documents adequately support the established regulatory strategies.
• With minimal supervision, manage routine development and post-approval regulatory activities.
• Maintains working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
• Archives and maintains regulatory submissions, correspondence, and other regulatory documents in compliance with regulatory requirements and SOPs.

Qualifications:

• BA/BS degree in life sciences discipline, Master of Sciences in Regulatory Affairs is highly desirable.
• At least 5-7 years of pharmaceutical industry experience, of which at least 4 years of Regulatory Affairs strategy drug development experience.
• Experience and knowledge in preparation of INDs, NDAs, and supportive amendments or supplements.
• Working knowledge of eCTD elements and structure, ICH standards, and submission requirements.
• Experience with small molecules and drug-led-device combination products preferred.
• Ophthalmic Therapeutic experience preferred
• Experience in Clinical Trial Authorization Applications in Canada, EU, and other regions/countries is preferred.
• Experience with eCTD (US and ex-US) and using Regulatory Information Management System preferred.
• Strong communication and regulatory writing skills.
• Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.
• Ability to balance multiple tasks to meet priorities and timelines.

#hybrid #lifesciences #pharmaceutical #smallmolecule #combinationproducts #regulatoryaffairs #drugdevelopment #ophthalmic #executivesearch #boston