About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Regulatory Affairs Specialist is responsible to independently perform the regulatory affairs relevant tasks and participate/execute inter-departmental communication and relevant compliance activities.

Main Responsibilities

• Manage regulatory strategies for medical device products and combination products.
• Lead discussions with regulatory authorities (e.g. FDA, EU and UK Notified Bodies) on product classifications and applicable regulatory standards.
• Provide regulatory guidance to product development teams to ensure compliance with applicable testing and study standards.
• Collaborate with quality teams to align on regulatory expectations for design transfer and manufacturing
• Support the development and implementation of QMS procedures to meet EU MDR 2017/745, US FDA and ISO 13485 requirements.
• Prepare and maintain regulatory documentation such as RA Strategies, Applicable Standards Lists (ARL), and more.
• Contribute to the preparation of regulatory submissions including 510(k)s, CE Mark, NBOp, DMF/MAF, and eCTD sections for IND/NDA/BLA/MAA.
• Monitor regulatory and standard updates relevant to our products and support technical SMEs with implementation plans.
• Support UDI updates and amendments to submission dossiers.

Minimum Qualifications

• Expertise in electromechanical medical devices containing software, ideally including infusion pumps or similar drug delivery devices.
• Proven experience with regulatory filings such as 513(g), 510(k), DMF/MAF (US), CE marking/Technical Files (EU).
• Proficiency in authoring and contributing to eCTD device sections in NDAs, BLAs, and MAAs; experience with NBOp is highly valued.
• Strong understanding of and experience with IEC 60601-1, IEC 60601-1-11, and AAMI TIR101.
• Familiarity with Taiwan FDA GMP license applications and medical device classifications.
• Experience preparing for and conducting regulatory meetings (e.g. Pre-Subs, Pre-IND, Pre-NDA/BLA).
• Fluency in both Mandarin and English (written and spoken) is required.

Preferred Qualifications

• Experience with mechanical autoinjectors, combination products, or primary packaging and sterile product manufacturing.
• Understanding of regulatory pathways and compliance for Software as a Medical Device (SaMD) and Digital Health products.
• Background in biologics or pharmaceuticals, especially related to combination products.
• Previous experience working in a global environment with regulatory approvals in the US and EU.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.