Regulatory Affairs Specialist

Job Description:

Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.

Job Requirements:

Reports to Role: Head of RA Regions & Registrations

Location (HQ or Region, Country, Site):

Istanbul, Turkey,  EH TURKEY SAĞLIK ÜRÜNLERİ VE HİZMETLERİ LİMİTED ŞİRKETİ. Fully remote

PURPOSE – in a few sentences, briefly describe the overall purpose of the role, i.e. why the role exists

The Regulatory Affairs Specialist supports regulatory affairs activities for international product registration by providing regulatory documentation and stakeholder support to ensure the timely regulatory approvals and maintenance of products in compliance with local regulatory requirements.

The Regulatory Affairs Specialist is accountable for timely execution of regulatory strategies to support launch activities and maintain compliance status for international product registration.

ACCOUNTABILITIES – describe role accountabilities/responsibilities, i.e. what the role does. Should cover the following:

The Regulatory Affairs Specialist is accountable for compliance and delivery for all assigned countries and registrations in Regions.

Regions & Registrations

• Contribute to development and execution of regulatory strategies for respective department projects, compliance projects as well as lifecycle management activities.
• Contribute to execution of International RA support projects for market access to REGIONS and ensure all RA related elements & requirements implemented.
• Align with local distributors and with local RA, understand requirements, and assists with the deliverables/ files related to preparing ROW submissions; uploads deliverables/ files into repository. Consults with others on these efforts as required.
• Prepare, order, and maintain oversight of all Free Sales Certificates, Certificates of Foreign Government and Country of Origin certificates requested for international regulatory approvals 
• Prepare core documentation "regulatory submission packages" for new product registrations in international markets 
• Prepare country specific documents for international regulatory approvals including, but not limited to manufacturer statements, Letters of Authorization and Power of Attorney  
• Review submission documents prepared by local RA to be used in country registrations 
• Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes 
• Conduct regulatory release and delisting of products using specialized regulatory software 
• Is aware of procedures and only makes decisions in line with procedure on simple topics 
• Plan out workload to deliver on time, able to make adjustments when required and prioritizing work together with manager 
• Prepare, and follow-up on International regulatory assessments for product changes 
• Closely monitoring together with local country representatives guidelines, regulations, changes in the marketplace and regulator positions for the assigned markets to ensure new requirements are caught, impact assessed and escalated if required 
• Close gaps created due to changed or new local country requirements by initatin projects and/or incorporating into global processes. 

• Support the provision of regulatory guidance to project teams in assigned projects and markets, in terms of requirements and related submission to support optimal timelines and required compliance levels. 

• Support the assembly of documents and the submission to authorities in countries of responsibility 
• Supports the monitoring of the regulatory environment and maintenance of the information resources 
• Support internal and external audits in the audit preparation and audit back office 
• Contributes and participates in the review of change requests to ensure compliance and the potential for regulatory submissions 
• May assist with reviews of promotional materials. 
• Has a yearly training program in place specified by manager. 
• Support the creation and maintenance of regulatory procedures and templates. 
• Can revise or create Technical Files. 
• Support the review of labels and IFUs 
• Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes 
• Tracks and maintains files on current status of licenses, registrations and product information as per agreed formats in the different systems in use by the organization 
• Can collect the regulatory compliance status of main countries, contribute to regulatory status of other regions of devices affected by HHE/Deviation/CAPA/Recall. 
• Provide internal trainings on requirements for area under their responsibility. 
• Knows and understands the EBS philosophy and employs it in daily RA activities and standard work. 
• Able to provide input in terms of activities required to be added to a DM or VPM. 
• Trained on PSP procedures to solve standard problems; analyzes information and standard practices to make judgments. 

KNOWLEDGE, SKILLS & EXPERIENCE – Functional/technical competencies specific to the role and required to perform the role

Critical Knowledge and Qualifications: (what the role holder must know; including any required general or professional qualifications/education)

• A minimum of a Bachelor’s degree from accredited college or university is required.
• Basic knowledge of medical device quality management systems such as 21 CFR Part 820 and ISO 13485.
• Basic knowledge of international legislation in some countries.
• Knowledge of main general documents required as FSC & legalization process

Critical Skills/technical know-how: (what the role holder must be able to do)

• Fluency in English a must. Further languages is an advantage. 
• Able to communicate effectively with team members, project team members, manager and other stakeholders; this includes: able to listen and grasp key information, able to clearly convey straightforward information, able to read non-verbal communication, such as reading body language and able to give short presentations to RA team on straightforward information 
• Demonstrates and advocates for working together in the spirit of openness, honesty and transparency that encourages engagement, collaboration, respectful interactions and trust. 
• Seeks out diverse ideas, opinions and insights, and applies them in workplace. 
• Works closely with direct team and project teams and starts building up network of colleagues, stakeholders, SMEs and customers. 
• Is aware of procedures and regulations and is able to assess situation on simple topics  
• Creates clarity and direction amid complexity and develops solutions  
• Never compromises on patient safety. 
• Have a positive attitude and 'can do' spirit 
• Ability to be flexible and adaptable. Maintain a professional demeanor under pressure.  
• Demonstrate a commitment to getting the job done right and on time and prioritizing work together with manager. 
• Be able to manage several projects, tasks products and/or countries work load and takes ownership. 
• Have attention to detail to task in hand but also start seeing bigger picture / wider process. 
• Know when to ask questions.  

Critical Experience:

• Minimum 2 years' experience in regulatory affairs or associated field within medical device industry.

COMPETENCIES – Essential for the role

Determine max. 6 competencies, refer to List and Definition of Competencies

• Continuous Improvement 
• Planning and Organizing 
• Strategy execution 
• Driving Execution 
• Learning Orientation 
• Actively contribute to successful team 

Operating Company:

DEXIS

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.