Jobs

Director of Regulatory Affairs

MED-LOGICS, a leading innovator in the ophthalmic medical device industry, is looking for a moderately experienced, diligent Director of Regulatory Affairs to join our expanding team. This executive-level position requires knowledge of international and domestic regulatory requirements, excellent strategic planning skills, and the ability to lead and drive our regulatory efforts to ensure compliance and oversee all regulatory affairs.

Key Responsibilities:

• Oversee and manage all aspects of the Regulatory Affairs, ensuring that all regulatory compliance requirements are met.
• Develop and implement robust regulatory strategies to support product development and commercialization.
• Liaise with international and domestic regulatory bodies, such as the FDA and Notified Bodies, to ensure that MED-LOGICS’s products meet the respective regulatory requirements.
• Stay up-to-date on regulatory changes and advise on their potential impact on the company.
• Lead and manage regulatory submission processes and other relevant applications.
• Collaborate with internal departments and regulatory consultants to ensure regulatory compliance in all stages of product development, manufacturing, and distribution.
• Provide leadership and guidance to the QA Team, facilitating professional development and success.
• Lead Internal Audits and External Audit procedures while also preparing responses to regulatory agencies’ inquiries.
• Drive a culture of “compliance without compromise” throughout the organization.

Required Qualifications:

• A bachelor’s degree in life sciences, biomedical engineering, or a related field. An advanced degree (MSc, MBA, or PhD) is preferred.
• A minimum of 2 years experience in regulatory affairs in the medical device industry.
• Knowledge of domestic and international regulatory guidelines and practices (FDA, ISO, etc.), specifically, ISO 13485, ISO 14971, and 21 CFR 820.
• Excellent written and verbal communication skills with an ability to write technical documents.
• Proven ability to lead and manage a team.
• Exceptional organizational and strategic planning skills.
• Ability to collaborate effectively with multiple teams across the organization.

Preferred Qualifications:

• Professional certification in Regulatory Affairs or similar.
• Experience with regulatory affairs in a start-up or rapid growth environment.
• Experience in communicating and negotiating with regulatory bodies.

MED-LOGICS is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive and professional environment for all employees. We encourage all qualified applicants to apply and look forward to welcoming the successful candidate to our dynamic and innovative team.

Job Type: Full-time

Pay: $72,000.00 – $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• No nights

Ability to commute/relocate:

• Athens, TX 75751: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Please provide your full name, including any middle names.

Education:

• Bachelor’s (Required)

Experience:

• FDA regulations: 2 years (Required)

Work Location: In person

Email info@mlogics.com for more information on how to apply.

Job posted: 2023-05-24