Job Title:  Regulatory Affairs Specialist

Position Summary

The Regulatory Affairs Specialist serves as the primary regulatory liaison for new product development project teams. As such this person is responsible to attend team meetings; document regulatory classification and regulatory requirements; guide teams through design controls and risk management; prepare US regulatory submissions; contribute to generation of Technical Files ; liaise with International Regulatory and the labeling group on markets and timelines; and review all proposed labeling and design documentation. 

This person will assist the primary regulatory liaison to assigned manufacturing facilities. As such this person is responsible to assist in review of change requests and communicate any potential concerns with International Regulatory and Compliance as necessary; help provide regulatory input for management review; participate in production/post-production analyses; support the facility through regulatory audits and inspections; assist in review of special sales requests; review documents as part of internal review processes; and support the registration and listing process as requested.

The Regulatory Affairs Specialist helps support administrative functions within the Regulatory department including procurement of user fees and trending of regulatory data. In addition, the Regulatory Affairs Specialist is expected to have good command of the specific guidance, standards, and regulations applicable to a particular product type or technology.  These activities require close work with STERIS corporate domestic and international staff and will include interactions with FDA as assigned. The Regulatory Affairs Specialist will have responsibility, when assigned, for performing the duties of the functional areas described below under the guidance and direction of his/her manager and other senior Regulatory Affairs staff. 
 

Duties

510(k) Submission Support

1.    Assists senior Regulatory Affairs staff as assigned in writing, formatting, researching, compiling, reviewing, cross-checking , submitting, and generating appropriate responses to FDA requests relating to premarket notifications. With experience, may be called on to author submissions, key sections, or response documents.
2.    Maintains electronic submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
3.    Monitors current projects and pending and planned submissions to track timelines, identifies any unexpected delays, and communicates progress on projects and submissions to business partners.
4.    Responsible for ensuring that 510(k) or other necessary User Fees are paid and available as needed for any planned submissions.
5.    Handles any FOI requests to FDA, maintaining records of the communications and any payments made. Facilitates the completion of submission redaction requests received from the FOI office
 

Duties - cont'd

Product Development and Continuing Support

1.    Gathers information and documentation on proposed, newly acquired, or modified products to correctly determine product classification and submission and FDA listing requirements. 
2.    When serving as Regulatory advisor on product development team, acts as champion for compliance with design controls, good documentation practices, and risk management standards. Reviews documents carefully to ensure that user needs are clearly identified and required testing is planned to support the indications for use desired.
3.    Synthesizes and actively supports STERIS Regulatory Affairs management’s Regulatory Strategy and accurately communicates it to business partners throughout the project. Engages Regulatory management as necessary when changes occur or new risks or requirements are identified, and proposes actions as appropriate. 
4.    Generates checklists for product development team use to ensure completion of requirements.

Education Degree

Required Experience

1. Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, or pre-medical core concentration.  
2. 1- 2 years professional experience, preferably 2 or more years including regulatory, governmental compliance matters, quality systems, internal auditing, applicable scientific, engineering, or technical functions and/or healthcare industry experience.
3.  Professional certifications and regulatory, quality systems, or internal audit training certificates in relevant disciplines are desirable, although no particular certification is required.

Skills

1. Self-starter with demonstrated organizational, project management, time management and problem-solving skills is preferred. Ideally, has experience working effectively on cross-functional teams.
2. Demonstrated ability to balance multiple high priority responsibilities on-time and effectively.    
3. Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
4. Strong oral and written communication skills, especially scientific/technical writing skills.
5. Strong critical thinking skills. 
6. Excellent PC skills, including Microsoft Office applications.

What we offer

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.  

  #LI-SA2   #ZRSA-1