Overview

Primary role is to participate in product development activities with R&D from conception of new product to submission and deployment of new product. Participate in activities to ensure compliance with worldwide regulatory requirements.

What you'll do:

• Establish procedures to comply with cybersecurity regulatory requirements.
• Work with the RA team to help develop and implement process improvements throughout the regulatory processes.
• Participates in development teams and provides input to assure that worldwide regulatory requirements and standards are incorporated in the product development process and design/ manufacture of the product`s to ensure compliance with regulatory requirements for Class III Medical Devices.
• Collaborate with RA Country Managers to identify country specific requirements relevant to product development projects such as special testing and labeling requirements.
• Generate master submission documents to support worldwide submission activities including licence renewals & annual reports.
• Participate in the engineering change order process, by reviewing engineering and manufacturing document release and changes.
• Manage/Supports testing, training and implementation activities for quality system projects.
• Keep abreast of new or developments in various regulations and advise Regulatory Affairs management as necessary.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Responsible for ensuring compliance to all relevant quality system regulations, including EU MDR Regulation, ISO 13485:2016, 21 CFR Part 820, and all regulations applicable for MDSAP certification
• Develop, implement and manage procedures for regulatory compliance on cybersecurity.
• Provide guidance to Product Development Teams for Regulatory Compliance World Wide.
• Prepare submissions and manage any additional information Requests from the agencies.
• Provides guidance and training to other Regulatory Affairs team members in lower level positions.
• Other duties as assigned.

Travelling Requirement:up to 10%

What you bring to the team:

Education

• Bachelor's degree in a scientific discipline or engineering or additional equivalent work experience

Nice to Have

• Masters or PhD in a Scientific Discipline

Work Experience

• At least 10 years of experience in worldwide regulatory affairs (both submissions and compliance) at medical device companies.

Nice to Have

• Experience in the Class III medical device environment

Personal Competencies

• Critical Thinker, Highly organized, efficient and self-motivated
• Strong attention to detail, accuracy and ability to handle multiple tasks
• Ability to work under pressure and with cross-functional teams

Nice to Have

• Project management skills
• High learning aptitude and adaptability with systems and regulatory landscape

Social Competencies

• Self-Motivated Team player who seeks to help and learn from colleagues
• Excellent interpersonal, communication, and negotiating skills

Leadership Competencies

• Ability to communicate persuasively in a manner that supports approvals and other key company goals/objectives

Professional Competencies

• Good working knowledge of Global requirement including EU MDR regulations and standards.
• Excellent writing, proof reading and data management skills
• Good working knowledge of class III medical device labeling requirements
• Excellent time management and problem solving skills

Nice to Have

• RA certification by Regulatory Affairs Professional Society

Language(s)/ Level

• English/ Proficient

IT Skills

• Proficient with Microsoft Office suite
• Working knowledge of cloud based systems
• SAP and Salesforce experience

Our offer:

• Exciting and challenging work environment
• Comprehensive benefits package
• Training and development opportunities - we believe every employee deserves a development plan. Come, learn, and grow with us!

Don't meet all the criteria? If you're willing to go allin and learn we'd love to hear from you!

We love to work with great people and strongly believe that a diverse team makes us better. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.

We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Senior Manager, Human Resources.

Pay Ranges:$91,200/yr - $136,800/yr

Based on location

Health Benefits & Perks:

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance
  • Additional supplemental life/ad&d coverage available
• Short/Long-Term Disability coverage (STD/LTD)
  • STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO & paid holidays*
• Employee Assistance Program

*Plan rules/offerings dependent upon group Company/location.