Post Market Surveillance Manager

Fisher & Paykel Healthcare; Berlin; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Benefits dieser Stelle

Employee share purchase plan

Generous paid parental leave

Life, critical illness and income protection insurance

Discounted health insurance

Free parking

Zusammenfassung

Fisher & Paykel Healthcare in Berlin is seeking a Manager of Post Market Surveillance. This role supports the Airvo and myAirvo product teams, focusing on leading post-market surveillance practices and ensuring compliance with regulatory standards.

The ideal candidate will have proven leadership experience in the medical device industry, along with strong communication skills to engage with senior management and regulatory authorities.

This position offers numerous benefits, including employee share purchase plans and generous paid parental leave.

Qualifikationen

• Proven leadership experience in the medical device and/or pharmaceutical industry.
• Minimum of 3 years in Quality and/or Regulatory Affairs.
• Experience with regulatory authorities during inspections and audits.

Aufgaben

• Lead all aspects of Post Market Surveillance for product teams.
• Minimize regulatory risk through data analysis and communication.
• Develop strategic plans for competitive advantage in surveillance.

Kenntnisse

Leadership experience in medical device and/or pharmaceutical industry

Communication with senior management

Team development

Expertise in US FDA requirements

Ausbildung

Bachelor degree or equivalent in engineering, science, business, or a related field

Jobbeschreibung

Relocation Support for Individuals & Families:

• Full Immigration support
• Relocation Flights + Additional Baggage
• Temporary Accommodation
• Rental Car

About the opportunity

This role is a Manager of our Post Market Surveillance team supporting the Airvo and myAirvo (Nasal High Flow) Product Teams based out of New Zealand for FPH globally. Reporting to the Head of Global Post Market Surveillance, this role is critical to supporting our global business by leading all aspects of post‑market surveillance.

Responsibilities

• Leading all aspects of Post Market Surveillance, specifically supporting the product teams in identifying, assessing and acting upon potential risks in the field.
• Minimising regulatory risk through the analysis and communication of Post Market Surveillance data internally and externally with regulatory authorities.
• Contributing to the development and deployment of global Quality & Regulatory strategic plans.
• Developing and deploying strategic plans that provide a competitive advantage in post‑market surveillance.
• Leading and developing a high‑performing team of quality & regulatory professionals that achieves strategic business objectives.
• Continuously improving post‑market surveillance practices and tools to be world class.

Qualifications

• Proven leadership experience in medical device and/or pharmaceutical industry.
• At least 3 years in Quality and/or Regulatory Affairs with a deep understanding of regulatory requirements, including specific expertise in US FDA requirements.
• Ability to effectively communicate with senior management and key stakeholders across a global business.
• Ability to engage and develop a high‑performing team.
• Experience in communicating and interacting with regulatory authorities during external regulatory inspections and audits.
• At a minimum, a university degree (Bachelor degree or equivalent) in engineering, science, business, or a related field.

Quality is at the heart of our success as we constantly strive to ensure the very best for our customers. Your valued contribution is vital to this, and this could be the role for you.

Working With Us

H UsCare to join a supportive environment? Fisher & Paykel Healthcare fosters an inclusive work environment founded on our culture of care and cooperation. Here you’ll have the trust and support to generate ideas, solve problems and do your best work, while enjoying some of our perks and benefits.

Benefits

• Employee share purchase plan
• Discretionary bi‑annual profit sharing
• Generous paid parental leave
• Life, critical illness and income protection insurance
• Discounted health insurance
• Active social clubs & community groups
• In‑house training programs from external providers
• Purchasing privileges for Fisher & Paykel Healthcare
• School holiday programme scholarship
• Banking and insurance discounts
• Free parking
• Beautiful campus with green spaces
• High rates of internal promotion
• Access to state‑of‑the‑art facilities

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. Our commitment to care unites us. Here, we’re driven to improve patient care and outcomes through inspired and world‑leading healthcare solutions.