Principal Engineer-Medical Affairs Specialist

Work Flexibility: Hybrid

Who we want

• Analytical - Synthesizes complex or diverse information; Collects and researches data; uses intuition and experience to complement data; designs workflows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in both group and as an individual
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Communication – Develops a working relationship with the key stakeholders to ensure alignment must work well in a team environment
• Self-motivated – Effectively commits self to achieving and takes advantage of opportunities

Position Summary:As a Principal Medical Affairs Specialist, you will ensure successful preparation of high quality submission-ready clinical documentation related to clinical submissions. Your primary role involves translating complex scientific and technical information into accessible content for various audiences. You will work closely with cross-functional teams (Marketing, Research and Development, Regulatory, and Quality), ensuring successful preparation of high-quality submission-ready clinical documents such as clinical evaluation documents, Post Market Clinical Follow-up documents, and Summary of Safety and Clinical Performance.The Principal Medical Affairs Specialist will report to the Spine CQR Manager and will work directly with divisional counterparts in Regulatory, PMS and medical affairs group. The role will support Post Market efforts related to CERs, PMCF documents, and SSCPs. In this critical role you will have the ability to influence and evolve our product security needs at the product and program levels.What you will do

• Recruit, onboard, train and manage talent for building organizational capabilities.
• Manage deliverables (protocols, reports, literature searches, succinctly summarizing scientific content) and metrics with efficient planning, scheduling and resource allocations.
• Author clinical trial protocols, interim and final clinical study reports, integrated safety/performance data summaries from raw data as applicable.
• Perform formal literature searches, and succinctly summarize scientific content for assigned projects. Interprets literature information and synthesizes the information in clinical regulatory documents.
• Provide clinical science subject matter expertise and consultation to clinical research associates, biostatistics, data management, regulatory affairs, medical Safety and other internal and external stakeholders.
• Compiles clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesizes the information in support of EU- MDR submissions, required CERs, and annual updates.

What you need:

• A minimum of a bachelor’s degree (BA or BS) in a technical and/or scientific discipline required.
• Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) is required
• 8+ years of Industry experience in medical technology or pharma is required
• 6+ years of experience in Scientific or Medical Writing, relevant academic or clinical research experience (Masters or PhD) is preferred.  
• Expertise in interpreting information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
• Expert knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents required.
• Excellent scientific and medical writing skills required.
• Must be able to think analytically, have the ability to interpret data from scientific literature and clinical studies and synthesize the results and in a clear, concise, and scientifically accurate manner in the clinical document.
• Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses.
• Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred.
• Excellent knowledge of regulatory guidelines (FDA/CFR; EN540/ Med DEV/GCP/EU MDR/MDCG) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology.
• Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation required.
• Motivated, self-starter with the ability to work with minimal supervision, make independent decisions, technical aptitude, attentiveness to detail, and excellent communication skills.
• Good planning and organizational skills, with the ability to adapt and adjust to changing priorities.
• Strong communication, project management and influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
• Builds strong relationships by fostering open communication, respect and trust.
• Act with a customer service/stakeholder-focused approach.
• Leverages excellent interpersonal keys to achieve desired outcomes..

Qualifications & experience:

• Analytical - Synthesizes complex or diverse information; Collects and researches data; uses intuition and experience to complement data; designs workflows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in both group and as an individual
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Communication – Develops a working relationship with the key stakeholders to ensure alignment must work well in a team environment
• Self-motivated – Effectively commits self to achieving and takes advantage of opportunities

Physical & mental requirements:

• Must be able to effectively manage multiple conflicting priorities in fast-paced environment.
• Must be able to learn and absorb product knowledge quickly and efficiently
• Must be able to communicate effectively via phone and email.
• Ability to operate common office equipment.

Travel Percentage: 10%