Regulatory Affairs Specialist
4 hours ago
We are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Accordance Search Group.
This is a challenging and rewarding role that requires a strong understanding of regulatory requirements and a proven track record of success in ensuring compliance.
Key Responsibilities- Develop and implement regulatory strategies to ensure compliance with FDA and international regulations
- Prepare and submit regulatory applications, including 510(k) applications and PMA supplements
- Coordinate and compile regulatory submissions, including European Dossiers and other country-specific product registrations
- Represent Regulatory Affairs on cross-functional product development and manufacturing support teams
- Maintain annual licenses, registrations, and listing information
- Assist with compliance to product post-marketing approval requirements
- Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities
- Reviews, edits, and approves Advertising and Promotional materials
- Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies
- Maintains ongoing surveillance and analysis of all pertinent medical device regulations
- Bachelor's Degree in a scientific discipline, e.g. Chemistry, Life Sciences, Biology
- Minimum 5 years' experience working with Class II and/or Class III medical devices
- Regulatory Affairs Certification (RAC) is a plus
- Experience with 510(k) applications, PMA supplements, and US device regulations, or with EU and other international medical device regulations and submissions
- Must be familiar with relevant regulatory requirements for medical devices, including Quality Systems standards and clinical investigations
- Experience with word processing, spreadsheet, and presentation graphic software packages
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Ability to identify, solve problems, and work independently with little oversight
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes, and meets deadlines in a timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to travel approximately 5%, including international travel
- Ability to maintain regular and predictable attendance
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