Enter a job title or keyword
Senior Manager Regulatory Affairs – Medical Devices
Job Location:
Job Location:
Covington, OH - USA
Yearly Salary:
USD 150000 - 165000
Yearly Salary:
Posted:
5 September 2026 (9 days ago)
Posted:
Application Deadline:
3 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
OPEN JOB: Senior Manager Regulatory Affairs Medical Devices
LOCATION:Covington Georgia
***Relocation Assistance Available
***WFH on Fridays
BASE SALARY: $150000 to $165000
INDUSTRY:Medical Equipment / Devices
Responsibilities
Job Qualifications
If you are interested in pursuing this opportunity please respond back and include the following:
Upon receipt one of our managers will contact you to discuss the position in full detail.
STEPHEN FLEISCHNER
Recruiting Manager
INTERMEDIA GROUP INC.
EMAIL:
LINKEDIN: Experience:
LOCATION:Covington Georgia
***Relocation Assistance Available
***WFH on Fridays
BASE SALARY: $150000 to $165000
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 companys product portfolio.
Job Qualifications
- Bachelors 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:
LINKEDIN: Experience:
Senior Manager
About Company
your search ends here innovative staffing solutions for job seekers as well as corporate and government clients nationwide for over 20 years View All Our Openings About Us Intermedia Group, founded in 1996, provides expert staffing services for our clients’ full time salaried employee ... View more
