Regulatory Affairs Manager

Work with a world leader in development and manufacture of medical devices at Synapse Biomedical Inc. (SBI) in Oberlin, OH.

You will have the opportunity to contribute your skills on devices that significantly improve the lives of others, including Diaphragm Pacing, which has been developed in collaboration with Case Western Reserve University and the University Hospitals of Cleveland.

Our culture as a small company is best described by its people : smart, driven, energetic and committed to improve the lives of individuals with neurological impairment, such as spinal cord injury, and others.

Collaborate and grow with us while helping others live a better life. Competitive pay and benefits.

Job Summary :

Responsible for assuring all global regulatory activities and reporting are performed in accordance with applicable regulatory requirements, and assist in executing quality system functions.

Duties and Responsibilities :

Primary responsibilities include :

• Completing (and / or acting as liaison to external agencies to complete) regulatory submissions for product introductions and enhancements, including obtaining cost quotes, timelines, and submission content;
• Oversee and provide input for regulatory planning as part of development projects;
• Review of complaints for appropriate follow-up action;
• Oversee, execute, and assist with periodic and event-based submissions to regulatory authorities, including :

o MDR and vigilance reporting

o Annual / periodic reports for approved products and in-process studies

o Facility and small business registrations

o Clinical study submissions (IDE, ethics committee)

• Review and reporting of product performance to meet quality system and regulatory requirements;
• Assist in implementation and maintenance of QMS;
• Participate in external and internal regulatory / compliance audits;
• Maintain visibility to upcoming global regulatory changes to allow sufficient time to affect any required changes to products or processes;
• Create management review content related to regulatory activities;
• Review of company activities for compliance with regulatory requirements.

Required Knowledge, Skills, and Abilities :

• Working knowledge of FDA Quality System Regulations, ISO 13485, MDSAP, and EU Medical Device Regulation
• Knowledge of other global standards / regulations desirable
• Experience with 510(k), PMA, HDE, IDE, CE Mark
• Ability to independently manage and execute periodic regulatory reporting requirements
• Quality and / or Regulatory credentials and memberships desirable
• Above average communication, writing, and interpersonal skills
• Proficient with Microsoft Office and online regulatory reporting mechanisms

Required Credentials and Experience :

• Minimum of 5 years' experience in quality and regulatory positions in medical device manufacturing
• 10 years of experience preferred
• Minimum of a Bachelor's degree in a regulatory or technical discipline, or equivalent combination of education and

experience required

• Graduate degree in a regulatory or technical discipline desirable
• RAPS, Quality Manager, Quality Engineer, Quality Auditor certifications desirable

This role does not have direct reports.

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