Sr. Regulatory Affairs Specialist

Tecomet, Inc•Warsaw, IN

2d•Onsite

About The Position

The Sr. Regulatory Affairs Specialist will be responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. This role ensures the company adheres to all relevant laws, regulations, and standards, requiring good knowledge of industry regulations and effective communication skills to guide and inform various stakeholders. The Specialist will ensure that regulatory-related requirements from customers are communicated clearly and concisely to all employees to meet domestic and international customer and governmental regulatory requirements. Additionally, the Sr. Regulatory Affairs Specialist assists in teaching regulatory requirements and best practices to team members and conducts first and second-party audits to assess adherence to the QMS and domestic as well as international regulations. This is accomplished by maintaining Tecomet principles of Safety, Quality, Customer Satisfaction and Innovations.

Requirements

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.
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

Nice To Haves

Bachelor of Science Degree Preferred.

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
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
Additional functions and requirements may be assigned by manager as deemed appropriate