Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

LivaNova

Munich, Germany

General Responsibilities

• Participating on product development project teams to provide input to ensure that appropriate regulatory requirements for market clearance or clinical trials are built into project plans;
• Developing regulatory submission applications to introduce new or modified devices, new or expanded indications for use or changes to the manufacturing/quality processes into the marketplace;
• Participating in meetings with regulatory officials for purposes related to market approval;
• Providing senior management practical operations-oriented interpretation of regulatory requirements governing medical devices;
• Responding to registration requests from regulatory authorities;
• Reviewing advertising and promotional literature;
• Maintaining regulatory files to ensure the company’s compliance with regulatory requirements;
• Implementing initiatives to enhance efficiencies, productivity, and quality that are consistent with company changes and growth without adversely impacting quality or regulatory compliance;
• Developing and reviewing quality system documentation such as Clinical and Regulatory strategic plans, procedures, verification and validation protocols and reports, investigation (e.g., complaint or CAPA) and clinical protocols and study reports;
• Collaborating with Clinical Affairs, Product Development, Quality, Marketing and Operations to drive best practices into project and fulfill design control activities and other Product Development Projects/New Products deliverables in a timely manner;
• Ensure local regulatory requirements are met prior to distribution.

Skills and Experience

• A minimum of a BS in Engineering, Life Sciences, Pharmacy, Nursing or Mathematics/Statistics is required;
• Graduate degrees in biomedical or clinical engineering (Research-based MS and PhD) from recognized university programs are preferred;
• Several years experience working in a regulated environment industry such as FDA/EU MDR Class 2 or 3 (or equivalent international classification) medical device manufacturer;
• Possesses appropriate knowledge of pertinent regulations to assure regulatory submissions and the departments procedures meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfill such requirements;
• Understanding of basic clinical and regulatory principles including, but not limited to: clinical trial design and methodology and knowledgeable of world-wide clinical and regulatory environments we compete in;
• Pragmatic and result-oriented: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders;
• Time management: able to independently manage large technical writing projects to complete per schedule;
• Strong interpersonal skills. Able and willing to challenge technical and strategic approaches;
• Strong written and verbal communication skills in English and in any other relevant language(s);
• Strong technical writing skills; able to efficiently and effectively write large submissions in English;
• Proficient in MS Office including Word, Power Point, and Excel;
• Travel up to 25 %.