Manager Regulatory Affairs (m/f/d)

Novanta, Inc.; Deutschland; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global healthcare technology company is seeking a Manager Regulatory Affairs to ensure compliance and timely regulatory approvals for medical devices. The ideal candidate will have 8-12 years of experience in regulatory affairs, strong leadership qualities, and excellent communication skills. The position involves managing interactions with regulatory bodies and supporting product launches across global markets. Located in Berlin, the role may require up to 10% travel.

Qualifikationen

• 8-12 years of professional experience in regulatory affairs.
• Knowledge of medical device regulations.
• Ability to effectively communicate with regulatory agencies.

Aufgaben

• Manage regulatory submissions and approvals for medical devices.
• Interface with customers and regulatory bodies.
• Maintain compliance with quality and safety regulations.

Kenntnisse

Extensive expertise in regulatory affairs

Leadership experience

Ability to take responsibility

Good communication skills

Quality-oriented

Ausbildung

Degree in natural sciences, engineering, or medical field

Advanced training 'Manager Regulatory Affairs for Medical Devices'

Jobbeschreibung

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing-improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications-from minimally invasive surgery to robotics to 3D metal printing.

Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.

This position is part of Novanta's Advanced Surgery business unit. Specialized in the field of Minimally Invasive Medicine, Advanced Surgery develops devices and accessories so that doctors can operate with small cuts. We produce eg Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures. Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate.

Summary

The Manager Regulatory Affairs is responsible for regulatory submissions and approvals for initial placing and maintaining the devices on the market are timely performed.

To make this happen the employee anticipates and plans appropriate tasks and coordinates relevant cross-functional teams.

Your expertise will support successful product launches and compliance throughout the product lifecycle.

Management Responsibilities:

• Technical and disciplinary management of the subordinate areas and employees.
• Designing, developing and optimizing the structure and processes of the subordinate areas.
• Assignment, development and scheduling of employees according to requirements and skills
• Conducting regular employee appraisals
• Carrying out and implementing resource and budget planning for the subordinate areas.
• With regard to occupational safety and environmental protection, the prevention of occupational accidents and environmental damage, occupational diseases and work-related health hazards, the manager is entrusted with the responsibility for creating and maintaining facilities for his area and for issuing instructions and taking other measures to ensure, maintain and improve occupational safety and environmental protection.

Primary Responsibilities

Regarding Regulatory approval of medical devices:

• Management of or responsibility for the compilation of approval-relevant documents including free sales certificates, legalizations, other declarations, and certificates
• Management of or responsibility for compiling documents for documentation evaluations by notified bodies and competent authorities worldwide
• Management of or responsibility for the control/acceptance of technical documentation as part of the conformity assessment procedure, assessment of compliance with the essential requirements, preparation, and release of declarations of conformity

Regarding Customer Support and External Contacts:

• Interface between the RA departments of customers, the notified body and authorities
• Support for audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMR

Regarding Safety-related incidents:

• Management of safety-related complaints in cooperation with the Medical Affairs team

General Tasks

• Initiation and management of the processing of measures to maintain the QMS (e.g. process adaptation)
• Initiation of innovation process
• Strict compliance with the quality, occupational safety and environmental regulations
• Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist

Required Experience, Education, Skills, Training and Competencies

• Long-term (8-12 years) of extensive and well-founded functional professional experience
• Leadership experience is required
• Knowledge, creativity, ability and willingness to take responsibility to put multiple and sometimes contradictory inputs into context
• Completed studies in the natural sciences, engineering, medical or comparable field
• Possess extensive expertise in regulatory affairs, with a specialized background in the medical device industry
• Advanced training "Manager Regulatory Affairs for Medical Devices"
• Languages: English Level CEFR C1*, German Level CEFR B2*
• Independent, Quality-oriented, reliable, and dependable
• Self-motivated
• Team player
• Be able to effectively communicate with internal stakeholders, regulatory agencies, and external partners
• Well-structured and systematic way of working

Travel Requirements

• Willingness to travel to different NOVT locations and business partners - Up to 10% traveling time

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Novanta is proud to be an equal employment opportunity and affirmative action workplace. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.

Please call [phone] if you need a disability accommodation for any part of the employment process.