Senior Manager Regulatory Affairs

Job Description

Job Description

Strivector Corp is a National Recruiting and Staffing agency established in 2012 and headquartered in Austin, Texas. We are a preferred partner for several Fortune 500 companies nationwide. Strivector has been consistently rated a rare 4.6/5 on Google, Indeed and Glassdoor by our candidates, customers, employees and contractors.

Elevate your professional journey with us. Strivector s premier client (a well-known market leader in their space) is hiring for the following full-time direct hire position.

POSITION OVERVIEW

As a Senior Manager Regulatory Affairs your roles and responsibilities will include:

• 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

• 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

ADDITIONAL INFORMATION
Compensation: Based on Experience. One of the best in the industry
Minimum Education: Bachelor's Degree
Minimum Experience: Minimum of 8-10 years of experience in Regulatory Affairs within the medical device industry

Type of position: Full-time Permanent position with benefits
Location: Covington, Georgia

Remote / Hybrid: NO
Relocation accepted: Yes