Regulatory Affairs Specialist M/F

With 1,500 employees, 14 production sites, and 23 logistics and sales sites across 3 continents, Sterimed is the world leader in sterilization packaging solutions for medical devices. Sterimed develops, produces, transforms, and markets various types of solutions (bacterial barriers and pre-formed sterilization packaging) for both hospitals and medical device manufacturers.As an LBO group, Sterimed is characterized by a strong entrepreneurial DNA and has pursued a very dynamic external growth policy for several years. Since its founding in 2016, the size of the group has increased 4.5 times, and 10 acquisitions have been made since 2017.The position is based at Ridgeville, our brand-new facility, providing a dynamic and stimulating environment that offers ample opportunities to innovate and contribute to the company's growth.JOB SUMMARYAs part of its ongoing commitment to regulatory excellence, Sterimed is strengthening its Regulatory Affairs team to support its growth in North America and beyond. The increasing global regulatory requirements"”especially in the U.S. (510(k) submissions), Canada, and Europe (MDR)"”demand agility and expertise to ensure compliance across our expanding product portfolio.The Regulatory Affairs Specialist plays a central role in navigating complex regulatory landscapes, driving product approvals, and ensuring compliance with evolving industry standards. This position will focus on supporting the regulatory needs of our Ridgeville (USA) and potentially Mexico sites, working on 510(k) submissions and related regulatory activities.This role will involve supporting Quality Management System (QMS) initiatives, ensuring compliance with ISO 13485, FDA Quality System Regulation (QSR), and other relevant standards.Working within a multicultural, cross-functional environment, this position offers exposure to strategic regulatory projects, including product validation, sustainability initiatives, and regulatory submissions across multiple markets.To strengthen our regulatory expertise and support our growing global operations, we are looking for a Regulatory Affairs Specialist MF.DUTIESRESPONSIBILITIESLead and manage 510(k) submissions for Sterimed products manufactured in Ridgeville and Mexico.Ensure compliance with FDA regulations, including 510(k) submissions, as well as Health Canada requirements and other applicable regulatory frameworks.Oversee product design control, validation, labeling, and promotional regulations for medical devices.Develop and maintain regulatory documentation, including validation protocols, risk assessments, and technical files.Collaborate with Quality Assurance (QA) and R&D teams to support product development and regulatory compliance.Monitor and interpret changes in global medical device regulations to ensure Sterimed's compliance.Work closely with external regulatory agencies and partners, including U.S. agents for FDA communication.Provide regulatory support for product sustainability initiatives, ensuring alignment with U.S. regulatory expectations on packaging and environmental compliance.Contribute to post-market surveillance efforts, ensuring compliance with clinical evaluation and safety requirements.Quality Management System (QMS) responsibilities:Support compliance with ISO 13485 and FDA Quality System Regulation (QSR).Assist with internal and external audits to ensure regulatory and quality compliance.Participate in CAPA (Corrective and Preventive Actions) processes and non-conformity investigations.Contribute to validation activities, including process validation and product testing.Maintain and improve regulatory documentation and quality records in alignment with QMS requirements.CHALLENGES AND FUTURE PROSPECTS The regulatory landscape is constantly evolving, requiring adaptability and proactive engagement to ensure compliance with new standards and expectations. This role presents an opportunity to develop deep expertise in international regulatory affairs, gain experience in 510(k) submissions, and contribute to the quality and compliance strategy of a global industry leader. With the growing need for efficient regulatory approvals, this position provides significant career development opportunities within Sterimed's expanding global operations.REQUIRED SKILLS ABILITIES QualificationsEducationBachelor's or Master's degree in Engineering, Regulatory Affairs, Life Sciences, or a related field.3-5 years of experience in regulatory affairs within a medical device, pharmaceutical, or clinical research setting.Experience in 510(k) submissions (mandatory) and knowledge of ISO 13485, FDA, MDR, and other international regulations.Key SkillsAnalytical Skills: Ability to interpret regulatory requirements, assess compliance risks, and develop mitigation munication: Strong ability to clearly convey complex regulatory information to various stakeholders, including cross-functional teams and regulatory bodies.Problem-Solving: Capacity to develop innovative solutions to regulatory and quality challenges.Technical Writing & Documentation: Strong skills in writing, editing, and structuring regulatory documents, including 510(k) submissions, validation protocols, and risk assessments.Project Management & Organization: Ability to manage multiple projects and deadlines while ensuring compliance with evolving regulations.Collaboration & Cross-Functional Work: Comfortable working independently and within cross-functional teams in a dynamic, multicultural environment.Preferred QualificationsExperience with Health Canada submissions.Knowledge of U.S. Agent requirements for FDA interactions.Background in product validation (ISO 11607 compliance).WHAT WE OFFER • Paid Life Insurance - $50k coverage• Paid Short Term Disability• Paid Long Term Disability• HealthDental insurance benefits: 92,5% of the premium cost for employee and 50% of premium cost for spouse and dependents is paid by Sterimed.• 401k with 100% employer match of contribution up to 6% of gross earnings - Eligible to enroll after 6 months of employment, with enrollment periods starting on either July 1st or January 1st. Vacations: 2 weeks year, 1 day compensation per working day when travelling or meeting over the weekend.Sick LeaveHolidays:• One week sickpersonal time• Paid Holidays: As defined in the Sterimed policy (around 10 days for 2023)Sterimed is committed to creating an inclusive and accessible work environment for everyone. Please do not hesitate to inform us of any accommodations needed to facilitate your participation in the recruitment process.

Created: 2025-02-21