Sr. Regulatory Affairs Specialist Job Description Template
Our company is looking for a Sr. Regulatory Affairs Specialist to join our team.
Responsibilities:
- Monitor impact of changing regulations on submission strategies;
- Submit and review change controls to determine the level of change and consequent submission requirements;
- Determine and communicate submission and approval requirements;
- Provide regulatory input for product recalls and recall communications;
- Provide regulatory input to product lifecycle planning;
- Assist with label development and review for compliance before release;
- Assess external communications relative to regulations;
- Review and approve advertising and promotional items to ensure regulatory compliance;
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes;
- Analyze the input of cumulative product changes to current product submissions;
- Interact with regulatory authorities during the development and review process to ensure submission approval;
- Determine trade issues to anticipate regulatory obstacles;
- Supports the cross functional teams with regulatory guidance during all design control phases of a new product or major changes;
- Support and maintain product registrations in the US, EU, Asia;
- Support VP of Regulatory Affairs with premarket and post-market reports, documentation.
Requirements:
- Certified regulatory affairs professional would be desirable;
- Background in Software as Medical Devices a Plus;
- 5 plus years of relevant experience in a medical device company (FDA Class I or II equivalent – Class III a plus);
- Bachelor’s degree in a technical / healthcare / business discipline or equivalent;
- Microsoft Office; Word, Excel, Publisher, PowerPoint;
- RAC Certification is an advantage;
- Experience submitting to the FDA and OSU (outside of the US);
- Previous experience with pre-market and post-market activities for medical devices;
- Experience with diabetes, hospital products, software and app development preferred;
- Ability to manage multiple projects, take initiative to answer questions;
- Must work well independently or within a cross-functional team environment;
- Up to 10% domestic travel;
- Experience with US, EU, Canadian, Australian market regulations;
- Working familiarity with ISO 13485/14971, MDD 93/42/EEC, 21 CFR 820, Risk Management;
- Bachelor’s degree in Engineering or other technical field.