Senior Regulatory Affairs Specialist
Edge Systems is expanding FAST, and we have a great opportunity for an experienced and talented Senior Regulatory Specialist to lead our international product registration projects.
This opportunity is perfect for you if:
- YOU are Regulatory Specialist with responsibility for Class II device registration experience in markets outside the U.S. (CE mark experience is a must) AND
- You bring over 7+ years total experience in Regulatory Affairs role with a medical device manufacturer.
- Your writing skills are exemplary, specifically in technical file and submission documents.
- You thrive in a fast-paced environment where you have to manage multiple projects at one time, and you are known by your colleagues as someone who can communicate complex regulatory requirements and technical data in an understandable way for any audience.
- You are someone who is known to be resilient and resourceful – a self-starter who can make decisions and take action without having to check in with your boss at every step.
IN this role, you will be a key contributor bringing the company’s products into new markets and spearheading our OUS device regulatory submissions. You will author and compile technical documentation for submissions, licensing and re-licensing, and change reporting. Your diligence in researching relevant regulations and conducting impact/gap analyses will ensure smooth implementations in your assigned markets. Working directly with department leadership, you will assist in creating and implementing regulatory affairs policies and procedures that ensure regulatory compliance is enhanced and maintained. You will also serve as the internal subject matter expert for regulatory affairs in the design and development projects you lead, including product labeling and claim review.
YOU will love this role, because…..
- You will work side by side with your Regulatory Affairs Manager handling your own market submissions.
- You will be part of a small but mighty team with exposure to the senior leadership team of this fast-growing business so the opportunity for recognition and promotion is guaranteed.
- You will have the autonomy and authority to lead your regulatory submissions from start to finish.
- You’ll manage multiple device applications simultaneously and will interface directly with regulatory bodies, agencies, OUS distributors and other international stakeholder to resolve application issues.
- Edge for Life is a profitable business with a proven, effective and patented technology with our award-winning HyrdraFacial® and Perk™ brands.