Senior Regulatory Affairs Specialist (m/f/d)

This position is part of Novanta’s World of Medicine (WOM) business unit. Specialized in the field of Minimally Invasive Medicine, WOM develops devices and accessories so that doctors can operate with small cuts. We produce 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.

Tasks

Primary Responsibilities

Medical device approval:

• Self-responsible compilation of registration-relevant documents on request of customers in third countries incl. free sales certificates, legalizations, other declarations and certificates
• Self-responsible compilation of documents for documentation tests by the Notified Body of W.O.M. within the scope of approval procedures according to EU Medical Devices Directive
• Control/acceptance of technical documentation within the framework of the conformity assessment procedure, assessment of compliance with the Essential Requirements, preparation and release of declarations of conformity.

Design control and change management:

• Elaboration and updating of design guidance procedures and subordinate policies and procedures.
• Contribute to the execution of the risk management process, clinical evaluation and usability file as part of the design steering process.
• Review/approval of regulatory documents in the context of design governance, in particular:
  Risk Analysis/Risk Management, Clinical Evaluation, Design Validation/Design Verification Plans and Protocols, Software Documentation, Instructions for Use and Product Labels.
• Processing of change processes and checking for relevance to approval
• General inquiries regarding RA and contact person for interpretation of standard requirements e.g. for steri-validation, biocompatibility, electrical safety etc.

Customers and externals:

• Interface to the RA departments of the customers, to the Notified Body and authorities
• Accompaniment of audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMB

Safety-related incidents:

• Handling of safety-related complaints in cooperation with the QM team

General tasks

• Initiation and active participation in measures to maintain the QMS (e.g. process adaptation)
• Active participation in the innovation process
• Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions from quality/environmental management representatives and the occupational safety specialist

Responsible/authorized to make decisions

• Delivers complex and diverse problem solutions that require extensive evaluations.
• Acts as a consultant to less experienced personnel and also trains accordingly.
• Performs primarily technical and some process related leadership duties.

Requirements

Required Experience, Education, Skills, Training and Competencies

• Several years (2-5 years) of relevant professional experience
• Ability to conduct extensive research, in-depth knowledge and creativity
• Anticipate, identify, define and solve the most complex problems. Ability to analyze proposed solutions to solve problems with far-reaching and long-term implications
• General knowledge of the manufacturing process is required
• Quality-conscious, trustworthy and reliable
• Willingness to travel to all locations and business contacts
• Team player
• Communicative skills
• Structured and systematic way of working

Additional qualifications:

• Manager Regulatory Affairs – Medical Devices
• Independent use of English (CEFR-B2)*

Benefits

• Flexible working hours & home office option
• Further Training opportunities & training program
• International career opportunities
• Free Drinks in the office
• Employee referral program
• Team & site events
• Childcare allowance
• Birthday presents
• Anniversary Bonus
• Mobility allowance
• Company Benefits
• Company health management
• Ergonomic workplace concepts

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