Senior Manager Regulatory Affairs – Medical Devices

Intermedia Group•Covington, GA

3d•Hybrid

About The Position

We are seeking a highly experienced Senior Manager of Regulatory Affairs for Medical Devices to join our team. This role is crucial for developing and implementing regulatory strategies, ensuring product compliance, and leading a team of regulatory professionals. The position is based in Covington, Georgia, with relocation assistance available and the flexibility of working from home on Fridays. The ideal candidate will have a strong background in medical device regulations and a proven track record of successful submissions and product commercialization.

Requirements

Bachelor's degree in a scientific or technical discipline (e.g., Biomedical Engineering, Chemistry, Biology) required.
Minimum of 8-10 years of experience in Regulatory Affairs within the medical device industry.
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.
Proficiency in regulatory information management systems and tools.

Nice To Haves

Advanced degree (MS, PhD) preferred.
RAC (Regulatory Affairs Certification) preferred.

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.