What are the responsibilities and job description for the Quality Assurance Regulatory Affairs Manager position at Confidential?
Regulatory Affairs Manager – Consumer Health | $130,000–$150,000 Benefits
A high-growth, investor-backed consumer products company is seeking a Regulatory Affairs Manager to support U.S. and international regulatory strategy across a portfolio of consumer health and wellness products.
This role is regulatory-led and suited to someone who enjoys working cross-functionally in a fast-paced, scaling environment where compliance and commercial agility go hand in hand.
Key Responsibilities:
Regulatory Affairs (Core Focus)
- Drive regulatory strategy and submissions for U.S. and select international markets.
- Prepare and maintain 510(k) submissions and other required regulatory filings, where applicable.
- Oversee product registrations, technical documentation, and regulatory records.
- Review labeling, packaging, and marketing materials to ensure compliance and claims substantiation.
- Monitor evolving FDA, FTC, and other relevant regulatory requirements and provide practical guidance to internal stakeholders.
- Partner closely with R&D, Marketing, Supply Chain, and Legal to support compliant product launches.
Quality & Compliance (Supporting Scope)
- Contribute to ongoing quality systems and documentation processes.
- Support complaint review, corrective actions, and supplier quality activities as needed.
- Promote best practices in regulatory compliance across the organization.
Qualifications:
Required
- Bachelor’s degree in a scientific or technical discipline.
- 3–6 years of Regulatory Affairs experience within medical device, consumer healthcare, CPG, or FMCG environments.
- Demonstrated experience with regulatory submissions and product lifecycle documentation.
- Strong working knowledge of U.S. regulatory frameworks; international exposure a plus.
- Experience reviewing labeling and product claims for compliance.
- Ability to operate effectively in a lean, growth-stage business environment.
Preferred
- RAC certification or advanced regulatory training.
- Experience supporting mixed portfolios (device OTC/cosmetic categories).
- Multilingual capabilities a plus.
Salary : $130,000 - $150,000