On behalf of our clients, R.S.M.C is seeking a Quality and Regulatory Manager
3 months Term
Benefits: Eye Care, Dental , Medical
Pay rate: $40.00/hr
Remote Work Available
3-10 years Experience Required
The primary role of Quality Assurance function is to ensure that management systems are maintained and refined to ensure business compliance, meet regulatory frameworks and to support the design, development and manufacture of products that meet our quality requirements. Key deliverables include creating and building relationships with medical device regulatory in the USA. Ensure timely registration to meet business needs. Also, responsible for all aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems. Provides broad business technical support around QA systems and processes to the organization. Leads and implements significant quality projects across the business and also creates and improves quality and business processes. Capability and process development for compliance and Continuous improvement. Global responsibility for QMS alignment across global quality systems. Maintenance and security of documentation system and record keeping. Acts as Management Representative.
The Manager of Quality and Regulatory will lead all aspects of quality and regulatory related to Inova Labs Inc. (doing business as "Aria Health") and be a key contributor to the overall team effort. Our first product is Aria Free™, a compact home-based compression therapy treatment for lymphedema. The Manager will ensure we deliver on our promise of high quality and that we meet the expectations of regulatory agencies. In addition, the Manager collaborate with Product Development to release new products for commercial distribution.
Duration: 3 months, temp-to-hire opportunity
Primary Location: Manager is located in San Diego, CA- this position is remote and may work outside of San Diego.
Interview Process: HireVu then Zoom/Video Hours:
Flexible. We require support of business activities in San Diego, Sydney AUS and Singapore, which requires availability in late afternoon and early evening
Roles & Responsibilities
Support of post-market compliance.
Develop and refine regulatory strategy for products, manufacturing and distribution.
Provide regulatory guidance to product development regarding design, development, evaluation, or marketing of products.
Development of regulatory submissions to U.S. health agencies to gain product approvals and business licensure in accordance with business objectives. May direct external consultants in the preparation of complex submissions, such as 510(k).Maintain FDA establishment registrations and medical device listings.
Review of labeling and promotional material.
Respond to complaints and queries on FDA-related and other regulatory related issues.
Provide responses to regulatory agencies regarding product information or issues.
In-depth knowledge of regulatory and quality, standards, and regulations applicable to medical device business operations (e.g. ISO 13485:2016, FDA 21 CFR 820)
In-depth knowledge and experience with global medical device regulatory submissions.
Detail oriented &highly organized.
Strong interpersonal skills.
Strong analytical, writing, and verbal communication skills.
Work independently and exercise judgment with limited supervision.
Creative and resourceful.
Proficient in Microsoft Word, Excel, Power Point, decision-flow charting software and navigating the Internet.
+5 years related experience.
Accreditations related to either quality or regulatory from organizations such as ASQ or RAPS.