Regulatory Affairs, Medical Device

Expertise Development and Client Engagement:

• Cultivate and expand expertise in regulatory areas pertaining to Medical Devices, In Vitro Diagnostics (IVD), and/or Software as a Medical Device (SaMD), engaging with potential clients and staying updated on industry trends.
• Actively participate in client bid defense meetings for prospective projects across the medical device, IVD, and SaMD sectors, providing valuable insights and strategic guidance.

Advisory Consulting Services:

• Monitor regulatory changes globally and provide proactive advisory services to companies in the medical device, IVD, and/or SaMD sectors, ensuring compliance with new regulations and standards.
• Offer specialized Subject Matter Expert (SME) consulting on regulatory strategy, submissions, and operational excellence tailored to each sector's unique requirements.

Documentation and Compliance Support:

• Assist in developing technical documentation and design dossiers to facilitate CE marking, 510(k), or other approval procedures for medical devices, IVDs, and SaMD.
• Provide SME consulting for regulatory compliance, covering EU Directives, new EU Regulations (MDR & IVDR), FDA requirements, and other relevant regulations applicable to medical devices, IVDs, and SaMD.

Gap Analysis and Process Improvement:

• Lead comprehensive gap analysis projects for MDR, IVDR, and SaMD regulations, assessing existing systems, processes, and departments against new requirements.
• Collaborate with stakeholders to identify necessary changes to compliance processes and update associated documentation for each sector.

Risk Management and Quality Assurance:

• Support the implementation of changes to organizational risk management processes for medical devices, IVDs, and SaMD.
• Conduct thorough device risk assessments and ensure compliance with ISO 13485, MDSAP, and relevant regulatory standards for each sector.

Technical File Development and Submission Support:

• Aid in constructing Technical Files according to new MDR & STED format for medical devices, IVDs, and SaMD, including essential requirements evaluation reports, risk management documentation, and clinical evaluation reports.
• Provide support for regulatory submission projects across medical devices, IVDs, and SaMD, ensuring adherence to market and product-specific requirements.

Client Relationship Management and Project Oversight:

• Establish and maintain professional relationships with direct and indirect clients in the medical device, IVD, and SaMD sectors, including Health Authorities and Notified Bodies.
• Take responsibility for operational project planning across all sectors, preparing weekly plans aligned with project timelines and ensuring team members are appropriately trained.

Market Intelligence and Marketing Support:

• Stay updated on market news and trends across medical devices, IVDs, and SaMD, sharing relevant insights with the team and clients.
• Support marketing activities such as webinars, blog writing, and participate in presales meetings with prospective clients across all sectors.

Audits and Reporting:

• Assist in internal and external audits as required, ensuring compliance with regulatory standards for medical devices, IVDs, and/or SaMD.
• Provide regular status reporting to stakeholders according to an agreed communications plan, encompassing all sectors.

Education & Experience:

• Bachelor’s Degree in pharmacy, Regulatory Affairs, or relevant Life Sciences fields; Master’s Degree preferred.
• RAC certification in Medical Devices is advantageous.
• Minimum 5 years of experience in medical devices, IVDs, or SaMD within industry, consultancy, or regulatory agencies, with expertise in manufacturing, R&D, quality, or regulatory roles.

Skills and Competencies:

• Technical proficiency in MDD/MDR, IVDR, ISO 13485 standards, and IMDRF requirements across medical devices, IVDs, and/or SaMD.
• Strong stakeholder management and project management skills applicable to each sector.
• Excellent written and verbal communication, strategic thinking, and problem-solving abilities.
• Customer-focused mindset with strong organizational and time management skills, adaptable to diverse regulatory landscapes.