Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist 

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 Senior Regulatory Affairs Specialist is responsible for ensuring that SHL Medical AB’s products comply with applicable regulatory requirements and quality standards throughout their lifecycle. This role acts as a key liaison with global regulatory health authorities and drives the development and implementation of regulatory strategies to secure timely approvals and maintain product certifications. The position requires close collaboration with internal teams and external stakeholders to integrate evolving regulations into SHL’s Quality Management System (QMS), uphold the Quality Policy, and support continuous improvement initiatives.

Main Responsibilities

• Perform all activities in strict accordance with SHL Medical AB’s QMS, following the Quality Policy, Standard Operating Procedures (SOPs), Work Instructions, and the applicable quality training matrix.
• Serve as the primary company liaison with global regulatory health authorities.
• Develop and execute strategic regulatory plans for product development programs.
• Lead, prepare, author, and coordinate the delivery of regulatory submission dossiers for timely approvals.
• Manage SHL’s certificates, authorizations, and device registrations in accordance with applicable requirements.
• Drive and implement process and system improvements to optimize submission outcomes.
• Ensure integration of relevant regulations and standards (e.g., ISO 13485, ISO 9001) within the organization by participating in standardization bodies and industry forums.
• Guide management teams and departments to maintain compliance with up-to-date regulatory standards for medical devices and related products.
• Provide expert input on regulatory requirements and strategies during interdepartmental product development meetings.
• Develop and approve regulatory submission plans, GSPR/Essential Requirements checklists, and Declarations of Conformity (DoCs) as needed.
• Act as the coordinator and single point of contact between SHL, customers, and authorities throughout submission processes.
• Participate in design reviews as the Regulatory Affairs subject matter expert.
• Prepare, assemble, and submit all required global regulatory documents (e.g., Master Access Files, Common Technical Documents, eCTD) for various international markets.
• Provide clear guidance to cross-functional teams to ensure compliance with applicable regulations throughout the product lifecycle.

Minimum requirements

• Minimum 5 years of experience in a regulated industry
• Familiarity with FDA’s Quality System Regulations (QSR), 21 CFR 820, Good Manufacturing Practices (GMPs), Canadian Medical Device Regulations (CMDR), EU Medical Device Regulation (MDR 2017/745), and Combination Product 21 CFR Part 4.
• Working knowledge of relevant ISO standards, including ISO 13485 (Quality Management Systems for Medical Devices), ISO 10993 (Biological Evaluation of Medical Devices), and ISO 14971 (Risk Management for Medical Devices).
• Experience in FDA and EU product registrations.
• Fluent in English & Swedish, both spoken and written.

Preferred Qualifications

• Education: Bachelor’s degree in engineering or equivalent work experience.
• Prior experience in Regulatory Affairs preparing regulatory submissions such as NDA, aNDA, BLA,510(k), CE Marking, Notified Body Opinion (NBO) etc.…
• Experience in preparing and conducting regulatory meetings (e.g. Pre-Subs, Pre-IND, etc..)
• Experience with drug delivery devices including autoinjectors, combination products, or primary packaging and sterile product manufacturing.
• Experience with biologics or pharmaceuticals.
• Experience with second – and third-party audits.

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.   

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

For more information on SHL Medical, please visit: shl-medical.com/careers

Please note: We do not accept applications from recruitment agencies for this position.