Job Description

We are seeking a skilled and experienced Medical and Regulatory Writer to lead the clinical and regulatory documentation efforts for non-active implantable medical devices. This role will also be responsible for design and develop clinical protocols and execute clinical studies (pre-market or post-market studies) with minimal supervision. The candidate should have extensive experience in clinical evidence generation strategy and scope research topics to provide recommendations on clinical trial strategy. The ideal candidate will bring in-depth knowledge of international medical device regulations, robust scientific writing capabilities, and demonstrated experience in end-to-end clinical evaluation and evidence generation.

Key Responsibilities:

Clinical Evidence Development:

Author and maintain high-quality clinical documents including CERs, CEPs, PMCFPs, PMCFRs, PMSP, PSURs, and SSCPs in line with EU MDR and other international standards. Conduct thorough risk-benefit analyses and integrate data from preclinical, clinical, and post-market sources.

Cross-functional Collaboration:

Interface closely with R&D, Clinical Affairs, Marketing, and Regulatory teams to access and identify the necessary preclinical, clinical and technical information. Develop clinical and marketing communication tools such as peer-reviewed manuscripts, white papers, one-pagers, slide decks, surgical techniques, and more.

Scientific Literature Research & Analysis:

Design robust and reproducible literature search strategies. Perform systematic literature reviews and create comprehensive State of the Art summaries across diverse indications and implant technologies. Critically appraise scientific literature and write clinical summaries to determine evidence gaps, assist in research and development of clinical strategies for clinical investigational protocols.

Clinical Study Documentation:

Draft clinical trial protocols, ethics approval submissions, case report forms, informed consent documents, investigator brochures, clinical study reports, and support regulatory related submissions. Develop and manage clinical trial documentation: site master files, trial master files, Clinical trial logs, etc.

Clinical Operations & Oversight:

Lead clinical budgeting and financial management, including preparation and negotiation of trial budgets, oversight of vendor contracts and clinical study agreements, management of investigator, and site payments. Oversee aspects of clinical operations, including monitoring visits, generation of reports, and coordination with third-party CROs and sites. Draft clinical study agreements, insurance documents, and ensure operational compliance across trial activities. Initiate, monitor and close-out clinical studies on study sites in accordance with applicable national and international regulations, MDCGs, guidelines of ICH-GCP and NDCT-2019.

Regulatory & Compliance Frameworks:

Ensure documentation aligns with latest MDR 2017/745 and relevant guidance (e.g., MEDDEV 2.7.1 Rev. 4, MDCGs, ISO 14155:2020, ISO 14971, ICH-GCP, etc.). Interpret and apply risk management standards and post-market surveillance frameworks, contributing to proactive safety strategies.

Essential Requirements:

Domain Expertise:

Proven experience in authoring regulatory and clinical documents for non-active implantable medical devices.

Regulatory Acumen:

Solid understanding of relevant global regulatory frameworks, especially EU MDR, MEDDEV, MDCG guidance documents, ISO standards, and ICH-GCP guidelines.

Core Competencies

: Risk-benefit analysis Scientific writing (CER, BER, PMCF, PSUR, SSCP, etc.) Managing and supporting clinical studies/trials on medical devices Clinical trial documentation & project coordination Literature review & data appraisal Cross-functional communication and stakeholder engagement

Required Knowledge of Guidelines and Standards:

EU MDR 2017/745 MEDDEV 2.7.1 Rev. 04 MEDDEV 2.12/2 Rev. 2 MEDDEV 2.12/1 MDCG 2020-5/6/7/8 MDCG 2019-9 Rev.1 ISO 14155:2020 ICH-GCP New Drugs and Clinical Trials Rules, 2019 ISO 10993-1 ISO 14971 ISO 24971
Job Types: Full-time, Permanent

Pay: ?350,000.00 - ?450,000.00 per year

Benefits:

Commuter assistance Paid sick time Paid time off
Work Location: In person