Senior Manager Regulatory Affairs – Medical Devices

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: [email protected] (mailto:[email protected])
LINKEDIN: https://www.linkedin.com/in/stevefleischner/