OPEN JOB

Senior Manager Regulatory Affairs - Medical Devices

LOCATION

Covington, Georgia

•Relocation Assistance Available

•WFH on Fridays

BASE SALARY

$150,000 to $165,000

INDUSTRY:

Medical Equipment / Devices Responsibilities Develop and implement comprehensive regulatory strategies for new product development, product life cycle management, and post-market surveillance activities. Prepare, review, and submit regulatory documents, including 510(k)s, Dossiers, Technical Files, and other international submissions to global health authorities. Act as the primary regulatory contact for assigned projects, communicating directly with regulatory agencies during submissions, reviews, and inspections. Interpret and apply complex regulations, guidance documents, and industry standards to ensure product compliance throughout the development and commercialization process. Lead and mentor junior regulatory affairs professionals, fostering a culture of compliance and continuous improvement. Participate in internal and external audits, providing regulatory expertise and support. Assess the regulatory impact of product changes, manufacturing changes, and quality system changes. Collaborate effectively with R D, Quality, Clinical, Marketing, and other relevant departments to achieve regulatory objectives. Monitor and disseminate information regarding new or changing regulatory requirements and industry trends relevant to the company's product portfolio. Job Qualifications Bachelor's degree in a scientific or technical discipline (e.g., Biomedical Engineering, Chemistry, Biology) required. Advanced degree (MS, PhD) preferred. Minimum of 8-10 years of experience in Regulatory Affairs within the medical device industry, with at least 3-5 years in a leadership or senior role. Demonstrated expertise in preparing and submitting various regulatory applications (e.g., 510(k), PMA, CE Mark, International registrations). Strong knowledge of FDA regulations (21 CFR Parts 800s), ISO 13485, Medical Device Regulation (EU MDR), and other relevant international regulatory requirements. Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences. Proven ability to lead projects, manage multiple priorities, and work effectively in a fast-paced environment. RAC (Regulatory Affairs Certification) preferred. Proficiency in regulatory information management systems and tools. If you are interested in pursuing this opportunity, please respond back and include the following: MS WORD Resume required compensation. Contact information. Availability Upon receipt, one of our managers will contact you to discuss the position in full detail.

STEPHEN FLEISCHNER

Recruiting Manager

INTERMEDIA GROUP, INC. EMAIL

sfleischner@intermediagroup.com

LINKEDIN

https://www.linkedin.com/in/stevefleischner/