Senior Regulatory Specialist
Helps Sunrise Medical meet all state, local, federal, international, and industrial regulations that are applicable to the industry and the product offering. Routinely interact with regulatory bodies and government agencies as needed to perform the functions of the Regulatory Affairs Department. Evaluate current and new products for compliance with applicable regulations and perform regulatory filings where needed. Monitor and file adverse event reports, as needed. Support manufacturing employee competence / training and communications to organization as to QMS impact / changes and impact to organization and individuals.
PRINCIPAL JOB DUTIES & RESPONSIBILITIES:
- Daily review of reported complaints and/or returns for trending and identification of potential regulatory reporting and corrective / preventive actions.
- Contact customers / end users as required for additional follow-up on complaints / adverse events, as needed.
- Enter necessary data into the electronic databases, the complaint record system, and file adverse events and supplements as necessary. Escalate adverse events to Global Regulatory Board, as needed.
- Train other members of the QA / RA organization to ensure alignment between practices.
- Interact regularly with other Sunrise organizations worldwide to ensure alignment between practices including, but not limited to, QA / RA, R&D, Manufacturing, Marketing, Procurement, etc.
- Perform required activities as assigned in field notifications / actions or recalls, regulatory agency notifications, and/or agency submissions for clearance to market products in markets of entry.
- Correlate injury reports, failure analysis reports, and adverse event reporting with complaint data for investigation and determine required actions.
- Collaborate with Sales, Customer Service, Engineering, Manufacturing, and Quality Assurance in applicable areas / facilities in investigations.
- Work with Sr. Director of QA/RA and Chief Operations Officer to ensure documentation is appropriate, complete and in compliance with all applicable regulations.
- Review and provide input on all product information (print, electronic, or web) to ensure conformance with premarket notifications, regulatory filings, and labeling regulations.
- Create and implement compliance strategies / Regulatory Plans for newly developed products.
- Assess all new or improved products and determine whether regulatory agency filings are required.
- Participate in Risk Management activities.
- Generate Adverse Event and Vigilance Reports specific to applicable countries and ensure supplements are filed in a timely manner with appropriate follow-up and complete and accurate reporting.
- Prepare responses to customers and commercial teams as necessary per process and at the direction and oversight of the Sr. Director of QA / RA and Chief Operations Officer.
- Review / audit internal processes, as needed, and recommend / lead remediation activities for compliance gaps.
- Participate in External / Internal Audits and / or inspections.
- Special projects / assignments as requested.
- May be involved or responsible for other areas of Regulatory requirements as needed or requested by Senior Management.
- May be assigned other global Regulatory duties as assigned by senior management
- Work full-time in an office setting is required along with 25% travel (this requirement is dependent upon CDC recommendations for office settings and travel).
- Minimum 5-7 years of Regulatory and Quality experience and ability to perform each essential duty satisfactorily.
- Bachelor’s degree or equivalent experience. A Regulatory Affairs Professional Society [RAPS] Regulatory Affairs Certification [RAC] or equivalent is strongly preferred.
- Quality, Regulatory, and Operations experience in a manufacturing environment is strongly preferred.
- Ability to read and comprehend (in English) complex instructions, correspondence, and technical memorandums. Documents may include: government regulations, work orders, work instructions, product manuals, policies and procedures, etc.
- Ability to interact professionally and sensitively with customers (internal and external) and end users is required.
- Ability to communicate in a collaborative manner across all levels of the organization and to employ influential communication style to inform and recommend actions in gaining adherence to requirements.
- Ability to train others on regulations, application, and Quality Management Systems in general and specifically as relates to others’ job functions / level of responsibility in the organization.
- Strong communication and organizational skills with proficiency in technical writing. Ability to author policies, procedures, and work instructions.
- High level of computer proficiency with expertise in Microsoft Office applications, spreadsheets, data trending, and charting programs required.
- Strong analytical skills with the ability to work on problems of a diverse nature in which analysis of data requires evaluation of identifiable factors is required.
- The ability to exercise good judgment within generally defined practices and policies in selecting methods and techniques for data analysis and trending is required. Ability to solve problems in a practical manner. Need to have an ability to prioritize; manage multiple tasks; and work productively with all associates and customers (internal and external).
- The ability to work with no day-to-day supervision or instructions on routine work and only general instructions on new assignments is required.
- Detail-oriented with the ability to manage to strict timelines for reporting and communication.
- Strong work ethic and attention to detail is required.
- Knowledge of electronic complaint management systems is required.
- Experience interacting with U.S. FDA electronic databases (e.g., eSubmitter / WebTrader) is required.
- Must be able to work and participate in a team environment.
- Analytical Thinking – Approach problem-solving by using a logical, systematic, sequential approach.
- Diagnostic Information Gathering – Identify information needed to clarify a situation, seek that information from appropriate sources, and using skillful questions to draw out the information.
- Thoroughness – Ensure that one’s own and other’s work and information are complete and accurate; careful preparation for meetings and presentations; following up with others to ensure that agreements and commitments have been fulfilled.
- Fostering Teamwork – As a team member, the ability and desire to work cooperatively with others on a team; as a team leader, interest, skill, and success in getting groups to learn to work together cooperatively.
- Interpersonal Awareness – Noticing, interpreting and anticipating others’ concerns and feelings, and communicating this awareness empathetically to others.
- Influence Skill – Gaining others’ support for ideas, proposals, projects, and solutions.
- Building Collaborative Relationships – Developing and maintaining partnerships with others.
- Oral Communications – Express oneself clearly in conversations and interactions with others.
- Written Communication – Express oneself clearly in top-level business writing.
- Persuasive Communication – Planning and delivering oral and written communications that are impactful and persuasive with their intended audiences.
- Customer Orientation – Demonstrate concern for satisfying one’s external and/or internal customers.
- Stress Management – Functioning effectively when under pressure and maintaining self-control in the face of hostility or provocation.
Learn more here
Job posted: 2021-02-09