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
The ideal Senior Manager Regulatory Affairs would be someone with deep experience in many (if not all) of the following
- 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