Regulatory Senior Manager, Global Standards & Regulations (m/f/d)

LivaNova; München; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

A leading company in the medical device industry is seeking a Regulatory Senior Manager for Global Standards and Regulations to oversee regulatory operations and compliance processes. This pivotal role requires an engineering degree, strong organizational skills, and fluency in English. Candidates will have the opportunity to contribute to standard development and help maintain a supportive corporate environment that values equality and diversity.

Leistungen

Competitive base salary

Variable short-term & long-term incentives

Dynamic role in an advanced medical device environment

Recognition through the STARS Program

Qualifikationen

• Requires BS degree in Engineering or related technical field.
• Experience in medical device/quality systems preferred.
• Fluent in English, German language skills a plus.

Aufgaben

• Coordinate regulatory operations and manage external documents.
• Develop and maintain regulatory compliance policies.
• Collaborate with cross-functional teams for standards development.

Kenntnisse

Research

Organizational Skills

Communication

Problem-Solving

Ausbildung

BS degree in Engineering or technical discipline

Tools

MS Office

Jobbeschreibung

Join us today and make a difference in people's lives!

Regulatory Senior Manager, Global Standards & Regulations (m/f/d)

Position Summary

This position coordinates and manages standards and regulations surveillance process supporting of all LivaNova regulatory operations. This position reports to the Regulatory Affairs, Innovation department, to supervisor Senior Director, International Regulatory Affairs. The Position can be based in Germany or Italy.

Resposibility and Authority

• Support of processes related to global regulatory operations
• External Documents: administration of global processes for the monitoring, control, and communication of external documents applicable to LivaNova medical devices (e.g. international standards, medical device laws and regulations, regulatory guidance)
• Maintain electronic libraries and other resources to ensure LivaNova global access to current standards
• Influence and contribute to the development of standards through active participation in external standards organizations and other affiliated industry organizations

Primary Activities / Duties

• Responsible for execution of global external documents process, including periodic screening meetings and associated tasks
• Establish, update, and maintain policies to ensure compliance with regulatory requirements regarding standards.
• Responsible for generating/updating data and metrics used to update senior management on a periodic basis
• Identifies procedures and best practices for control of external documents
• Identifies and drives efforts for continuous improvement of external document processes.
• Complies with US FDA regulations, other regulatory requirements, Company policies, operating procedures, processes and task assignments.
• Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors and vendors

Additional Activities

• Performs other related duties and responsibilities, on occasion, as assigned
• This position may require business travel (less than 10 %)

Skills, Requirements and Qualifications

• BS degree in an Engineering or technical discipline (Electrical, Mechanical, Biomedical, or Computer preferred) or science
• Knowledge and understanding of medical device/quality system related standards, and in the design, development, and distribution of medical devices
• Experience working in a broader enterprise/cross functional business preferred
• Experience in standards development
• Strong research and organizational skills
• Resourceful, creative, well-organized with an ability to prioritize and proactively offer solutions
• Ability to work effectively within a team in a fast-paced changing environment
• Ability to work in a highly matrixed and geographically diverse business environment
• Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Prioritizes and meets deadlines
• Proficient in MS Office tools (Outlook, PowerPoint, Word, and Excel)
• Fluent English language skills, written and spoken; German language would be a plus

What we can offer you

In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:

• A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
• Exposure to a State-of-the-Art medical device development process, in close co-operation with international clinicians
• Competitive base salary
• Variable short-term & long-term incentives

• Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements

If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.