What are the responsibilities and job description for the Regulatory Specialist position at The Panther Group?
We are seeking an experienced Regulatory Affairs Specialist to support medical device compliance, regulatory documentation, and quality system requirements. This role focuses on Class I and Class II medical device programs, ensuring products meet FDA and ISO 13485 standards from development through production and customer delivery.
This is a hands-on, onsite position within a fast-paced, high-tech manufacturing environment.
Key Responsibilities
- Support regulatory compliance activities for Class I and Class II medical devices
- Develop, maintain, and organize regulatory documentation including DHF, DMR, and technical files
- Review and approve labeling, IFUs, specifications, and quality documentation for compliance
- Support change control activities and assess regulatory impact
- Assist with risk management activities in accordance with ISO 14971
- Support internal, external, and customer audits, ensuring audit readiness
- Partner cross-functionally with Engineering, Quality, Manufacturing, and Supply Chain teams
- Prepare regulatory responses, customer submissions, and compliance documentation
- Maintain up-to-date knowledge of FDA, ISO 13485, and global regulatory requirements
- Support supplier documentation and regulatory compliance activities
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field
- 8 years of experience in regulatory, quality, or compliance within medical devices
- Strong experience with Class I medical devices (Class II experience preferred)
- Working knowledge of FDA 21 CFR Part 820 and ISO 13485
- Experience with DHF/DMR, change control, labeling review, and audit support
- Strong documentation skills within a controlled QMS environment
Preferred Experience
- Experience with 510(k) submissions or EU MDR technical documentation
- Familiarity with ISO 14971, IEC 60601-1, IEC 62304, or IEC 62366
- Experience in contract manufacturing or electromechanical environments
- Experience with eQMS systems such as QT9, MasterControl, Greenlight Guru, or Arena
- Experience supporting customer or regulatory audits
Why Join
This is an opportunity to play a key role in bringing regulated medical device products to market while working in a collaborative, high-impact environment that values quality, compliance, and continuous improvement.
Note: This is a fully onsite role.
Salary : $120,000 - $160,000