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Regulatory Affairs Specialist
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Position: Regulatory Affairs Specialist
Department/Area: Regulatory Affairs
Authority:
- Authorized to sign documents issued by the Regulatory Affairs Department on behalf of the Regulatory Specialist for external and internal distribution.
Responsibilities/Activities:
The Regulatory Affairs Specialist is responsible for supporting and executing regulatory compliance processes for medical devices. This includes collaboration across internal teams, external customers, and regulatory bodies to ensure products meet relevant regulatory standards throughout their lifecycle.
Key responsibilities include:
- Managing medical device registrations for EMEA, Russia, and China.
- Supporting and executing regulatory review processes for product lifecycle and development to ensure compliance with MDR (Medical Device Regulation) standards.
- Maintaining and improving internal record-keeping systems, particularly regulatory files such as the Technical File (MDR Annex II & III or STED).
- Executing and assisting Post-Market Surveillance (PMS) activities in accordance with MDR requirements.
- Assisting in the development, review, and implementation of Standard Operating Procedures (SOPs).
- Supporting investigations and evaluations of regulatory guidelines, history, policies, and regulations related to specific products and markets.
- Assessing the regulatory impact on both current and new products.
- Contributing to the development and updating of regulatory strategies based on changes in regulations.
- Facilitating written and verbal communication with customers and regulatory bodies.
Supervisors:
Functional: Senior Regulatory Affairs Manager
Disciplinary: Director of QA/RA
Interface:
- Internal: Department staff (Q&RA), Department Manager, and Process Owner
- External: Customers and regulatory bodies
Representation:
- Represented by: Regulatory Affairs Manager
- Deputy for: None
Requirements/Qualifications:
Education:
- Bachelor's degree (BS) in Engineering, Physics, Chemistry, Biology, or a related discipline.
Experience:
- 3+ years of relevant experience in medical devices.
- Prior experience with FDA regulations and post-market surveillance (PMS) is required.
Knowledge:
- In-depth understanding of international regulations and standards including:
- Medical Device Directive (MDD) and/or Medical Device Regulation (MDR)
- ISO 13485
- MEDDEV 2.12/1 - Guidelines on a Medical Devices Vigilance System
- Medical Device Coordination Group (MDCG)
- FDA regulations, including 21 CFR Part 820 and post-market surveillance requirements (21 CFR Part 822)
Skills:
- Strong ability to evaluate complex medical and technological circumstances.
- Excellent written and verbal communication skills in both German and English, with the ability to communicate clearly with regulatory bodies.
- Firm understanding of regulatory compliance risks and escalation protocols.
- Strategic thinking, judgment, and problem-solving abilities.
- Ability to work effectively within a multi-functional team environment.
Technical Skills:
- Proficiency in MS Office, MS Project, and ERP systems.
Additional Requirements:
- Valid driver’s license.
- Ability to travel up to 10%.
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