Regulatory Affairs Manager

About the role

• Regulatory Affairs Manager lead all aspects of Regulatory Affairs related to medical devices regulatory submissions and submissions for global markets, supports all aspects of the Quality Management System, design and development, and distribution. This position works with internal and external teams.
• The Regulatory Affairs Manager reports to the Director of CA/QA/RA. 

What you'll do

• Act as backup for the Director of Quality and Regulatory Affairs and assist in audit activities (such as ISO, CE, MDSAP, California FDB). 
• Lead and expedite submission processes to obtain regulatory clearances worldwide to support corporate goals. 
• Ensure continued compliance with applicable local and international standards, regulations and laws related to the design, development, and distribution of medical devices. 
• Build necessary relationships with internal and external stakeholders. 
• Provide strategic advice to upper management to streamline global regulatory submissions and clearances. 
• Maintain corporate awareness of relevant regulatory environment and notify relevant personnel of regulatory changes that may impact project or corporate strategic plans. 
• Supports to maintain all applicable federal Facility Registrations and Listings, and State Licenses. 
• Research and execute clinical validation activities relative to usability and post-market surveillance as well as improvement of existing and new devices.
• Perform and/or assist with human factors usability studies. 
• Execute and/or assist with pre-clinical and clinical evaluations. 
• Maintain regulatory compliance and certification of existing products. 
• Supports the release of product to market. 
• Perform Risk Management for new and existing products as required. 
• Assist with Biological evaluations (Biocompatibility). 
• Support Software Verification and Validation. 

Qualifications

• Bachelor's degree with desired major areas including Law, Medicine, Pharmacy, Engineering, Science, or Manufacturing. 
• 10+ years of experience in regulatory and clinical affairs, or equivalent functions for medical device, pharmaceutical, or healthcare industries. 
• Experience organizing and leading meetings, communicating project progress, and ensuring actions are assigned/achieved. 
• Extensive experience in quality assurance with a strong understanding of all MDSAP regulatory requirements, including ISO 13485, 21 CFR 820 (U.S. FDA), Brazil RDC ANVISA 16/2013 and RDC 23/2012, Japan MHLW Ordinance No. 169, Therapeutic Goods (Medical Devices) Regulations 2002 (Australia), and SOR/98-282 (Canada). 
• Proven experience in managing audits (process, system, regulatory) and relationships with external constituencies. 
• Proven interpersonal, written, verbal, and problem-solving skills, with the ability to communicate and work collaboratively. 
• Basic MS Office skills. 
• American Society for Quality CQA or CQE and/or RAPS RCA certification(s) highly desirable. 
• Experience with risk management per ISO 14971. 
• Experience and/or understanding of compliance to IEC 60601-1, IEC 62304, IEC 62366, EN 60601-2-24:2015 and IEC 62366-1 and -2.

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