Regulatory Affairs Specialist
vor 3 Wochen
Stuttgart, Germany
- 23-06-2023
- JOB TYPE
- Permanent
- EMP TYPE
- Full-Time
- EXPERTISE
- General Management
- SALARY TYPE
- Annually
- SALARY
- Negotiable
I have partnered with a reputable medical device company specializing in the design, development, and distribution of high-quality spinal medical devices.
As a Regulatory Affairs Specialist, you will be a key contributor to our regulatory affairs department, focusing on Class I - Class III spinal medical devices. Your primary responsibility will be to lead and manage MDR projects, ensuring compliance with relevant regulations and standards.
**Key Responsibilities**:
- MDR Compliance: Stay abreast of the latest developments in MDR regulations and guidelines, particularly as they relate to spinal medical devices. Interpret and assess the impact of MDR requirements on our products and processes, providing strategic recommendations to ensure compliance.
- Regulatory Submissions: Prepare, review, and submit high-quality regulatory documentation, including Technical Files, Design Dossiers, and other required documentation for Class I - Class III spinal medical devices. Ensure submissions are accurate, complete, and adhere to relevant timelines and regulations.
- International Registration: Collaborate with international regulatory authorities, consultants, and distributors to register our spinal medical devices in target markets worldwide. Manage the regulatory approval process, ensuring compliance with regional requirements, standards, and documentation.
- Regulatory Strategy: Develop and implement regulatory strategies for new product introductions and modifications. Provide guidance on regulatory pathways, clinical evaluations, labelling requirements, and risk management to support product development and commercialization efforts.
- Cross-functional Collaboration: Work closely with internal stakeholders, including R&D, Quality Assurance, Clinical Affairs, and Marketing, to ensure regulatory compliance throughout the product lifecycle. Provide regulatory input and support during design and development, manufacturing, labelling, and post-market surveillance activities.
- Regulatory Intelligence: Monitor changes in regulatory requirements, guidelines, and standards related to spinal medical devices. Proactively communicate relevant updates to the organization and develop strategies to address regulatory changes effectively.
- Audits and Inspections: Support regulatory inspections and audits by competent authorities and notified bodies. Prepare necessary documentation, coordinate responses, and implement corrective actions as required.
**Qualifications and Skills**:
- Bachelor's degree in a scientific or engineering discipline. Advanced degree is preferred.
- Minimum of 3+ years of experience in regulatory affairs within the medical device industry, with a focus on spinal medical devices.
- Strong knowledge of MDR requirements and regulations related to Class I - Class III medical devices.
- Experience in preparing and submitting regulatory documentation, such as Technical Files, Design Dossiers, and international registration packages.
- Proven track record of successful regulatory approvals and product registrations in international markets.
- Excellent communication skills, both written and verbal, with the ability to effectively communicate complex regulatory concepts to cross-functional teams.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to work independently, prioritize tasks, and meet deadlines.
- Fluency in English and German is required. Additional language proficiency is a plus.
Reach out to me for a conversation confidentially
T: +44 1293 776644
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- Thomas Hatfield
- +441293776644
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