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 lifecycle management, and post-market surveillance.
- Prepare, review, and submit regulatory documents including 510(k)s, Dossiers, Technical Files, and international submissions.
- Serve as the primary regulatory contact for assigned projects and communicate directly with regulatory agencies.
- Interpret and apply complex regulations, guidance documents, and industry standards.
- Lead and mentor Regulatory Affairs professionals while fostering a culture of compliance and continuous improvement.
- Participate in internal and external audits and provide regulatory expertise.
- Assess the regulatory impact of product, manufacturing, and quality system changes.
- Collaborate with R&D, Quality, Clinical, Marketing, and other relevant departments.
- Monitor and communicate new or changing regulatory requirements and industry trends.
QUALIFICATIONS
Most importantly, you need to be a passionate
Senior Manager Regulatory Affairs who enjoys their work and is considered to be one of the best within your organization. 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 such as Biomedical Engineering, Chemistry, Biology, or related field.
- Advanced degree (MS/PhD) preferred.
- 8 10 years of Regulatory Affairs experience within the medical device industry.
- 3 5 years of leadership or senior-level experience.
- Expertise preparing and submitting regulatory applications, including 510(k), PMA, CE Mark, and international registrations.
- Strong knowledge of FDA regulations, 21 CFR Parts 800s, ISO 13485, EU MDR, and international regulatory requirements.
- Excellent written and verbal communication skills.
- Proven ability to lead projects and manage multiple priorities in a fast-paced environment.
- RAC certification preferred.
We understand that even if you are a seasoned
Senior Manager Regulatory Affairs, you may not have all the skills listed here.
ADDITIONAL INFORMATIONCompensation: Based on Experience. One of the best in the industry
Minimum Education: Bachelor's Degree in a Scientific or Technical Discipline
Minimum Experience: 8 10 years of Regulatory Affairs experience within the medical device industry
Type of position: Full-time Permanent position with benefits
Location: Covington, Georgia
Remote / Hybrid: Hybrid Onsite 4 days per week with Fridays remote
Relocation accepted: Yes, relocation assistance may be available for the ideal candidate