Key Responsibilities:
- Engage with medical device companies to understand their regulatory pathways, certification needs, and readiness for CE/MDR compliance.
- Provide guidance on conformity assessment routes, QMS requirements (ISO 13485), technical documentation expectations, and product classification.
- Communicate effectively with regulatory, quality, and engineering teams at client organizations.
- Support client preparation by explaining documentation requirements, validation expectations, and applicable standards.
- Participate in discussions regarding risk management (ISO 14971), usability engineering (IEC 62366), and product testing requirements.
- Generate leads and schedule meetings through email, phone, LinkedIn, and industry channels.
- Build and maintain strong relationships with medical device manufacturers, regulatory affairs teams, and quality leaders.
- Represent the company at trade shows, regulatory conferences, MDR/IVDR training events, and industry seminars.
- Manage the full sales cycle, including needs assessment, proposals, negotiation, and closing.
- Track KPIs, pipeline progress, and client interactions in the CRM.
- Collaborate with internal regulatory and auditing teams to ensure accurate communication of requirements and seamless client onboarding.
- Assist in preparing technical-oriented marketing content such as whitepapers, webinars, regulatory updates, and MDR guidance summaries.
- Conduct competitive and market analysis within regulatory compliance and Notified Body sectors.
- Gather client feedback to improve service offerings, technical explanations, and communication materials.
- Other related duties may be assigned from time to time.
Requirements:
- Bachelor’s degree in Biomedical Engineering, Regulatory Affairs, Quality Assurance, Life Sciences, or a related field.
- Minimum 1–2 years of experience in medical device regulatory affairs, quality assurance, compliance, auditing, validation, or certification support.
- Working knowledge of CE/MDR, ISO 13485, conformity assessments, risk management, and technical documentation requirements.
- Experience interacting with a Notified Body, FDA, or regulatory consultants preferred).
- Understanding of validation and verification activities, product testing, and clinical evaluation requirements (a plus).
- Strong communication and relationship-building skills.
- Comfortable with outreach via email, phone, and professional networks.
- Ability to work both in-office and remotely.
- Proficiency with office software, CRM tools, and documentation management systems.
- Valid driver’s license and ability to travel locally as needed.
Top Skills
What We Do
Manay CPA Inc. is a full-service CPA firm located in Atlanta, USA, that provides financial and tax consultancy for local and international businesses while providing a global platform for investment into the United States.
Manay CPA staff is composed of US and international professionals specialized in;
? New Business Formation and Consulting,
? Bookkeeping and Payroll,
? Tax Compliance and Planning,
? Sales Taxes and Business Valuations,
? Financial Guidance for Tech Startups,
? Financial and Retirement Planning,
? Financial Statement Preparation for VC investors.
With over 20 years of experience in the business world, we serve all 50 States of America and we’ve had more than 5,000 clients, so far, with 500 million dollars of trade volume.
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2001 yılında Atlanta, ABD’de kurulan Manay CPA Inc., Amerika Birleşik Devletleri dahilinde ve uluslararası alanda faaliyet gösteren işletmeler için çok çeşitli alanlarda hizmet veren, aynı zamanda yerel ve uluslararası firmalara finans ve vergi konularında uzman danışmanlığı sunan bir yeminli mali müşavirlik bürosudur.
Hizmet verdiğimiz alanlardan bazıları:
? Amerika’da Şirket Kurulumu,
? Yabancı Sermaye, Teşvik
? Muhasebe Hizmetleri,
? Kişisel ve Kurumsal Vergi,
? Bordrolama,
? Finansal ve Hukuki Konularda Stratejik Danışmanlık.
İş dünyasında 20 yılı aşkın tecrübemizle Amerika'nın 50 eyaletinin tamamında hizmet verebilir yetkiye sahibiz. Farklı sektörlerden, ticari hacmi 500 milyon doları bulan, 5.000'den fazla müşterimize mali müşavirlik hizmeti sunmaktan gurur duyuyoruz.
Sunduğumuz mali müşavirlik, finans ve muhasebe çözümlerinin yanı sıra, ABD'deki yatırımlarınız için de kapsamlı danışmanlık hizmeti veriyoruz. Şirket kurulumunuzun her aşamasında size destek oluyor, girişiminizi bulunduğu eyaletin regülasyonlarına v IRS'e uyumlu hale getiriyor, vergi planlamalarınızı yapıyor, teşvik ve vergi avantajlarından yararlanmanızı sağlayacak finansal modellemeler kuruyoruz.
