Sr. Regulatory Affairs Specialist

tecometunitedstates; Warsaw (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Tecomet is seeking a Sr. Regulatory Affairs Specialist to lead regulatory submissions, annual reports, and listings for domestic and international markets. You will ensure adherence to FDA, ISO, and industry standards, and guide stakeholders through regulatory requirements.

You will perform audits, support Declarations of Conformity, and participate in ISO audits and Technical File Reviews, while staying current with regulatory changes and advising senior management on risks.

Qualifications

• Minimum four years of experience in a quality and regulatory field or equivalent combination of education and experience.
• Bachelor of Science Degree preferred in a scientific discipline.
• Knowledge of FDA, ISO and medical device regulatory requirements.

Responsibilities

• Lead regulatory reviews of Tecomet standard products and customer co-development files.
• Collaborate with departments to address compliance issues and provide training.
• Create Declarations of Conformities and manage regulatory submissions.
• Participate in ISO audits and Technical File Reviews and monitor regulatory changes.

Skills

Regulatory knowledge

Audit experience

Documentation skills

Communication skills

Education

Bachelor of Science Degree

Tools

MS Word

Excel

PowerPoint

Job description

Sr. Regulatory Affairs Specialist

Position Summary

The Sr. Regulatory Affairs Specialist will be Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Ensuring that the company adheres to all relevant laws, regulations, and standards. The position requires good knowledge of industry regulations and effective communication skills to guide and inform various stakeholders. The Regulatory Engineer will ensure that the regulatory-related requirements from our customers are communicated clearly and concisely to all employees to ensure that the company meets domestic and international customer and governmental regulatory requirements. The Sr. Regulatory Affairs Specialist assists in teaching regulatory requirements and best practices to team members. Conduct 1st and second party audits to assess adherence to the QMS and domestic as well as international regulations.

This accomplished by maintaining Tecomet principles of Safety, Quality, Customer Satisfaction and Innovations.

Principle Responsibilities

• Field complaint investigations and reporting
• Perform regulatory reviews of Tecomet standard product and customer co-development design files to approve for release
• Collaborate with other departments to address compliance issues
• Provide training and support to staff on compliance matters
• Act as a liaison between the company and regulatory bodies
• Investigate and resolve compliance violations
• Stay updated with changes in regulatory landscape and industry standards
• Advise senior management on compliance risks and mitigation strategies
• Maintain current knowledge of relevant regulations
• Create Declarations of Conformities for release
• Regulatory reviews of memos to file
• ODCR reviews
• Participate in ISO audits and Technical File Reviews
• Annual review of all Tecomet products (PMS)
• Manage domestic/international medical device distribution submissions
• Participate in design reviews
• Maintain FDA MDL listings/submissions for Tecomet and Customer products
• Create and submit Certificates to Foreign Government for Tecomet products
• Participate in ISO audits and Technical File Reviews
• Conduct First and Second Party Audits to Regulatory Standards
• Effectively document clear and concise audit reports and findings
• Evaluate corrective action in response to observations made throughout audit process
• Annual review of all Tecomet products (PMS)
• Additional functions and requirements may be assigned by manager as deemed appropriate

Qualification Requirements

Credentials/Experience:

• Working knowledge of government(s), international, and national regulations regarding medical devices (i.e. FDA, MDD, CMDCAS, PAL, ISO etc.)
• Minimum Four years of experience in a quality and regulatory related field or equivalent combination of education and experience.

Experience/Educational/Training Preferred:

• Bachelor of Science Degree Preferred.

Knowledge, Skills, and Abilities:

• Ability to read, analyze, and interpret technical journals, technical procedures, and/or government procedures
• Ability to respond to common inquiries or complaints from customers, or regulatory agencies
• Ability to define problems, collect data, establish facts, and interpret technical instructions to draw valid conclusions
• Ability to handle multiple projects simultaneously
• Effective organizational skills
• Computer skills – Proficient in MS Word, Excel, and PowerPoint
• Familiarity with risk management and mitigation
• Manufacturing-related knowledge of medical devices to effectively conduct strategic process adequacy risk assessments
• Team-oriented attitude
• Ability to work in a proactive and reactive environment
• Ability to deal with complex and difficult situations unsupervised
• Ability to maintain confidentiality of information

Other Requirements

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.

Travel Requirements

Up to 10%