Regulatory Affairs Specialist II at Werfen GmbH

Bedford, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Jan, 26

Salary

105000.0

Posted On

30 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Communication Skills, Regulatory Affairs, Technical Review, Risk Management, Product Registration, ISO 13485, ISO 14971, In Vitro Diagnostics, SAP, QMS Systems, Labeling Review, Advertising Review, Data Analysis, Documentation, Training, Team Collaboration

Industry

Medical Equipment Manufacturing

Description

Overview Position Summary: Responsible for domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain domestic and international compliance. Responsibilities Key Accountabilities Essential Functions: Responsible to participate on design and risk management teams in the Hemostasis group as the Regulatory representative and provide guidance on domestic and international requirements, including: Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input. Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output. Prepare new product registration packages and technical files (e.g. CE Mark, 510ks, Canadian licenses). Provide support materials for Milan Regulatory for other country registrations. Assist with product renewal packages to maintain country registrations. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards. Responsible for maintenance of Regulatory Database in SAP. Responsible to review marketing and sign promotional materials for signature by management (as appropriate). Responsible to review and sign labeling and Change Orders (as appropriate). Educate and train Werfen personnel on domestic and international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated. Other assignments related to RA/QA to support Werfen requirements and priorities Budget Managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on department needs Skills & Capabilities: Requires superior communication skills (verbal and written) Proficiency with standard software (Word, Excel, PowerPoint, Adobe Acrobat etc.) Hands on experience working in a regulated environemnt following QMS systems. Previous experience and familiary with In vitro Diagnostics, software in medical device strongly preferred. Experience with SAP is a plus. Qualifications Minimum Knowledge & Experience Required for the Position: Requires a Bachelor degree, preferably in life sciences or engineering familiarity with ISO 13485 and 14971 preferred. Two years minimum experience in the Medical Device Industry or other highly regulated environment. International Mobility: Required: No Travel Requirements: Must be available to travel domestically and internationally as needed.

Responsibilities

The Regulatory Affairs Specialist II is responsible for domestic and international registration and renewal activities for Werfen-labeled products. This includes participation in design and risk management teams, authoring regulatory plans, and preparing registration packages.