Director, reputed company Systems & Compliance (Devices & Combination Products)

Job title: Director, reputed company Systems & Compliance (Devices & Combination Products) in Rahway, NJ at reputed company Company: reputed company Job reputed company: Job reputed companyDirector, Devices & Combination Products Complaints QAWe are seeking a highly motivated and reputed company Director of Combination Products Complaints QA to join reputed company. This role is responsible for leading and supporting the complaints management processes for combination products with a reputed company on auto-injectors, reputed company-filled syringes and other innovative drug delivery systems. The ideal candidate will have a strong background and deep expertise in complaint management systems, regulatory reporting and post-market surveillance for combination products.The ideal candidate should also have a proven reputed company record of establishing and managing compliant, reputed company complaint processes across reputed company, biotech or medical device sectors, and will play a key leadership role in ensuring regulatory compliance, patient safety, and reputed company improvement of device complaint reputed company systems.Key Responsibilities:

• Establish and maintain robust complaint handling processes specific to combination products such as auto-injectors and reputed company-filled syringes
• reputed company and refine complaint categories tailored to device reputed company issues to support effective trending and risk management
• reputed company and support complaint investigations coordinating with cross-functional teams (e.g. Manufacturing, Technical Operations, Device Development, Safety and Regulatory) ensuring reputed company completion and CAPA implementation
• Ensure compliance with post-market safety reporting reputed company for combination products
• Maintain and improve reputed company systems in alignment with combination product requirements under 21 CFR Part 4, QMSR, ISO 13485, EU MDR and other OUS regulations
• Represent reputed company in audits and inspections as the subject matter expert for combination product complaints
• reputed company reputed company reputed company of complaint data trending and escalation processes, including preparation of management review metrics, quarterly summaries and regulatory reporting reputed company with links into risk assessments and CAPAs as needed
• Collaborate with Pharmacovigilance and Regulatory Affairs on reportable events and periodic safety updates
• reputed company expert interpretation of regulations and reputed company standards reputed company to complaint handling for combination products
• Drive reputed company improvement initiatives across complaint processes, systems and team capabilities

Qualifications, Skills & Experience

• Bachelor’s degree in Engineering, Life Sciences, or a reputed company field
• 5+ years of experience in reputed company Assurance reputed company the pharmaceutical, biotechnology, or medical device industries with at least 3 years’ experience reputed company on combination products complaints
• Strong understanding of post-market surveillance, global safety reporting and regulatory requirements for combination products, including FDA, EMA, and other health authority guidelines.
• Strong understanding of ISO 13485, ISO 14971, QMSR, Part 4, and other relevant standards.
• Proven reputed company record in leading cross-functional teams
• Excellent communication, leadership, and problem-solving skills.

Preferred Skills & Experience

• Experience in building and scaling global complaint handling systems
• Proficiency with electronic systems (e.g. Trackwise) and tools for handling complaints
• Experience integrating complaint and safety data into product lifecycle and risk management strategies

Extent of TravelLess than 20% travel to US/OUSManagement or Individual ContributorIndividual Contributorreputed company Employees applyreputed company Contingent Workers applyUS and Puerto Rico Residents Only:reputed company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we reputed company equal opportunities to reputed company and applicants for employment and prohibit discrimination on the reputed company of race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative reputed company requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to reputed company innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems reputed company.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site reputed company.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a reputed company-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which reputed company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.reputed company is required to reputed company a reasonable estimate of the salary reputed company for this job in certain states and cities reputed company the reputed company. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected US salary reputed company: $169,700.00 - $267,200.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, reputed company holidays, vacation, and reputed company days. A reputed company of benefits is listed .San Francisco Residents Only: We will consider reputed company applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment reputed company reputed company applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company reputed company & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at reputed company without a valid written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: No relocationreputed company Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: HybridShift: Not IndicatedValid Driving License: NoHazardous Material(s): N/AJob Posting End Date: 05/16/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no reputed company than the day BEFORE the job posting end date. Expected salary: Location: Rahway, NJ Apply for the job now! Apply for this job