Sr. Regulatory Affairs Specialist

Tecomet Inc.; Warsaw (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

Tecomet Inc. seeks a Senior Regulatory Affairs Specialist to drive regulatory submissions, listings, and annual reports for medical devices across domestic and international markets.

You will lead audits, ensure QMS compliance, prepare Declarations of Conformities, and guide management on regulatory risks while coordinating with cross-functional teams to maintain product compliance and market access. The ideal candidate has four+ years in regulatory affairs, solid FDA/ISO knowledge, and strong

Qualifications

• Four+ years of regulatory experience in medical devices or equivalent field.
• Experience with FDA, ISO, and regulatory submissions.
• Strong knowledge of QMS and compliance requirements.

Responsibilities

• Field complaint investigations and reporting
• Regulatory reviews of product and design files for release
• Collaborate with departments to address compliance issues
• Provide training on compliance matters to staff
• Act as liaison with regulatory bodies
• Maintain FDA listings and regulatory submissions
• Participate in ISO audits and technical file reviews
• Annual review of Tecomet products (PMS)
• Prepare and issue Declarations of Conformities

Skills

Regulatory affairs

FDA regulations

Quality systems

Medical devices

Communication skills

Education

Bachelor's degree

Tools

MS Office

Document control software

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 1^st^ 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%