Regulatory Affairs Specialist

Are you a meticulous and detail-oriented professional with a strong understanding of regulatory landscapes in the medical diagnostics industry? Join MNM Diagnostics as a Regulatory Affairs Specialist!

MNM Diagnostics is a pioneering company in genetic diagnostics, dedicated to delivering innovative and reliable diagnostic solutions that positively impact patient care. We are seeking a highly organized and knowledgeable Regulatory Affairs Specialist to ensure our products and processes comply with all relevant national and international regulations. If you are passionate about ensuring quality and compliance in a dynamic scientific environment, this role is for you.

Your Responsibilities Will Include:

• Developing, preparing, and submitting regulatory documents and dossiers for new and existing medical devices (IVDs) in various markets (e.g., CE-IVD, FDA, national registrations).
• Interpreting and implementing new and updated regulations, standards, and guidelines (e.g., IVDR, MDR, ISO 13485, MDSAP).
• Acting as the primary point of contact for regulatory agencies and Notified Bodies, facilitating communication and inspections.
• Ensuring ongoing compliance of products and quality management systems with applicable regulations throughout their lifecycle.
• Providing regulatory guidance and support to R&D, Quality, Manufacturing, and Commercial teams throughout the product development and post-market phases.
• Reviewing and approving product labeling, marketing materials, and promotional content for regulatory compliance.
• Managing and maintaining regulatory databases and archives.
• Participating in internal and external audits to ensure regulatory adherence.
• Assessing the regulatory impact of product changes and managing associated submissions.
• Staying current with global regulatory trends and requirements in the IVD industry.

We Are Looking For Someone Who Has:

• Bachelor's or Master's degree in a scientific discipline (e.g., Biotechnology, Biology, Chemistry, Medical Sciences), Regulatory Affairs, or a related field.
• Proven experience (3+ years) in a Regulatory Affairs role within the medical device or in-vitro diagnostics (IVD) industry.
• In-depth knowledge of European IVDR/MDR, ISO 13485, and other relevant international regulations and standards.
• Experience with preparing and submitting technical documentation and regulatory submissions.
• Excellent written and verbal communication skills in English, with the ability to articulate complex regulatory concepts clearly.
• Strong analytical and problem-solving skills, with keen attention to detail.
• Ability to work independently and as part of a cross-functional team.
• Exceptional organizational skills and the ability to manage multiple priorities effectively.
• Proactive approach to identifying and addressing potential regulatory challenges.

What We Offer:

• An impactful role in a fast-growing, innovative company at the forefront of genetic diagnostics.
• Opportunity to work with a dedicated and multidisciplinary team.
• Competitive salary, comprehensive benefits package (private medical care, sports card, life insurance), and professional development opportunities.
• A dynamic and supportive work environment where your expertise is valued.
• The chance to contribute directly to patient health and scientific advancement.

If you are a highly motivated Regulatory Affairs professional ready to make a significant contribution, please send your CV and a cover letter detailing your relevant experience to: aplikuj@mnm.bio

Please include "Regulatory Affairs Specialist" in the subject line. We thank all applicants for their interest; however, only selected candidates will be contacted.