Job SummaryResponsible for supporting regulatory activities regarding released product, including, MDR investigations submissions, post market risk assessments (HHA), supports maintenance of the product Technical File in support of CE Marking, and risk management file updates. Leads field safety corrective actions/recalls, as required. Serves as a liaison between QA and manufacturing, R&D, customer service, and customers regarding complaint investigations, the identification of root cause, and the recommendation/coordination of Corrective/Preventative Action(s), when required.
Key Duties- Update and maintain technical files required for product approvals, including FDA submission documents, technical documentation for European Union and supporting regulatory submissions world-wide.
- Evaluates the regulatory impact of changes associated with product design change and routine
change control of instruments and software. - Work independently and/or cross functionally with various departments (e.g. sales, marketing,
customer service, R&D, manufacturing) - Provides direct support associated with adverse events, medical device reportable events and product recall activities, including corrections and removals.
- Receive, review and conduct investigations of escalated product complaints or assigned product quality issues, from data collection to investigation summary, including coordinating implementation or recommendation of follow-on quality system activities.
- Drafts, reviews, and helps provide guidance for product labeling activities, including package inserts, operator and/or service manuals, to ensure adherence to applicable regulations and standards.
- Provides regulatory input and oversight to product lifecycle planning, including risk management activities, and monitors product lifecycle and compiles information associated with changes as directed.
- Compiles new product technical information and feature summaries in support of market expansion.
- Examine complaint data to determine trends that may result in corrective action, report complaint trends to management and assist in post market compliance activities, including field safety corrective actions/recalls related to complaints.
- Responds to Sales & Marketing requests to ensure content of collateral and promotional materials are compliant with applicable regulations.
- Applies knowledge of device regulatory requirements (FDA and/or other International Regulatory Agencies) to support the Post Market Surveillance MDR/ADE reporting process.
- Lead post market risk assessment process and escalate critical issues for field action determination. Facilitate and manage the recall process when necessary.
- Provide support to R&D in the ongoing maintenance of product technical files that support US and international regulatory submissions.
- Review and analyze lot documentation (DHRs) to determine if there are any anomalies that may be related to reported product failures.
- Other duties as assigned.
Qualifications- Bachelor of Science degree in Biology, Biochemistry, Microbiology or related field required.
- A minimum of 4 years of direct Regulatory Affairs experience is required, including preparation of Pre-IDEs, 510(k) applications, EU Technical Files, Canadian Class II and III licenses, STED documentation, etc.
- Proven knowledge of FDA and ISO regulated environment (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices), including risk management principles (e.g. ISO 14971).
- Experience with design, development, and clearance of medical devices.
- Understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820, 803, 806; ISO 13485).
- Solid understanding and experience with CE marking, technical files and product registration requirements (domestic and international)
- Strong knowledge of post market regulatory compliance requirements
- Reasoning ability, support and prioritize projects - appropriately judging priorities, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts independently.
- Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
- Inquisitive and problem-solving mindset. Exceptional organizational skills, including time management.
- Strong interpersonal skills: ability to lead teams and facilitate team meetings.
- Effective communication skills, including verbal and technical writing skills.
- Knowledge based computer skills, such as MS office, outlook and excel
- Travel: 10%
- Compensation:101,600.00 - 131,900.00 USD
