Senior Specialist Regulatory Compliance

6942-ABIOMED Legal Entity•Cherry Hill, NJ

6d•$96,000 - $155,250•Onsite

About The Position

The Senior Specialist, Regulatory Compliance supports the MedTech Regulatory Compliance organization at Abiomed in Danvers, with a primary focus on internal audit execution, regulatory compliance, and audit and inspection readiness. The role leads and conducts internal audits, maintains audit reporting and governance, and works with business stakeholders and BioTeknika on FDA compliance remediation and preparedness for future inspections. The position also supports inspection readiness through documentation preparation, back-room coordination, subject matter expert coaching, CAPA support, GEMBA walks, and MDSAP and QMSR readiness tools. It works cross-functionally to identify and close compliance gaps, monitor risks and performance, and ensure remediation and readiness actions are completed on time. The role is responsible for communicating quality issues, adverse metric trends, and business-related issues or opportunities to management, and for following applicable company and regulatory requirements, including Health, Safety and Environmental practices. The anticipated base pay range is $96,000 to $155,250. Benefits described include retirement and savings plans, eligibility for a long-term incentive program, paid time off and leave programs, and medical, dental, and vision benefits, subject to applicable plan terms and policies.

Requirements

Bachelor’s degree in science, engineering, quality, regulatory affairs, or a related technical discipline.
At least 10 years of relevant medical device industry experience, with demonstrated knowledge of FDA, ISO, NMPA, and other applicable health authority regulatory and quality-system requirements.
Demonstrated experience working with Class III medical devices subject to FDA Premarket Approval requirements, including understanding heightened regulatory scrutiny, compliance expectations, and risk considerations.
Experience in Quality, Manufacturing, Engineering, Regulatory Compliance, or a related function.
Demonstrated auditing experience, including planning, execution, documentation, reporting, and follow-up of internal audits.
Experience leading, managing, or significantly supporting an internal audit program, including monitoring progress, timeliness, ageing, effectiveness, and closure of issues.
Experience communicating audit risk, progress, trends, and performance metrics through governance forums and escalating matters requiring management attention.
Experience supporting regulatory inspection and audit readiness, including compliance gap closure, SME preparation and coaching, CAPA coaching and storyboard development, documentation pre-pulls and organization, back-room support, GEMBA walks, and inspection logistics.
Experience supporting FDA compliance remediation with internal stakeholders, external contractors or consultants, and action owners.
Strong written and verbal communication and stakeholder-management skills across technical, quality, regulatory, and leadership audiences.
Ability to influence and collaborate across functions while maintaining ownership, accountability, and focus on timely closure of compliance commitments.
Ability to manage multiple priorities, identify matters requiring escalation, and maintain focus on audit execution, remediation progress, and sustained inspection readiness.
Ability to translate regulatory and quality-system requirements into practical, sustainable, implementable solutions.

Nice To Haves

Experience assessing organizational readiness against evolving regulatory and quality-system requirements, including MDSAP and QMSR.

Responsibilities

Serve as lead or team auditor for internal audits.
Execute internal audits according to established procedures and requirements.
Complete internal audit reports in the EtQ system, meeting documentation requirements and timelines.
Maintain adherence to the site internal audit schedule and established procedures.
Drive and maintain FDA inspection readiness following the Warning Letter, working with business stakeholders and BioTeknika to identify and close compliance gaps.
Partner with stakeholders and observation/CAPA owners to support timely investigation, corrective action, and closure of audit observations and CAPAs.
Report internal audit risks and performance through SEA Governance Tier 2 meetings, including progress, timeliness, ageing, effectiveness, emerging risks, and issues requiring escalation or corrective action.
Coordinate with BioTeknika on FDA compliance remediation priorities, deliverables, risks, and follow-through.
Support audit and inspection readiness, including back-room activities, documentation pre-pulls, and coordination of supporting evidence.
Prepare and coach subject matter experts for auditor and regulatory authority interactions.
Provide CAPA coaching and support development of CAPA storyboards covering issues, root cause, corrective actions, effectiveness, and evidence.
Plan and conduct GEMBA walks to assess operational readiness and identify potential compliance gaps.
Identify, document, track, and drive closure of compliance gaps and readiness actions.
Deploy and support MDSAP and QMSR readiness tools to assess preparedness, identify gaps, and support remediation.
Coordinate with cross-functional stakeholders and action owners to prioritize and complete compliance and readiness activities on time.
Create reports and communicate performance against metrics to cross-functional groups.
Identify and communicate adverse metric trends and take risk-based remediation action.
Proactively identify and alert management to quality issues that may adversely affect customers, company reputation, or the business.
Provide internal audit updates and inputs for Quality System Management Reviews.
Communicate business-related issues or opportunities to the next management level.
Follow applicable company Health, Safety and Environmental guidelines and ensure personal and company compliance with applicable laws, regulations, policies, and procedures.
If supervising or managing staff, ensure they follow applicable Health, Safety and Environmental guidelines and have the necessary resources.
Perform other duties as assigned.

Benefits

Consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the Company’s long-term incentive program.
Vacation: 120 hours per calendar year, subject to applicable policies and date of hire.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington, subject to applicable policies.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of the birth, adoption, or foster care of a child.
Bereavement Leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.
Medical, dental, and vision benefits, as well as time off and other benefits provided for in the applicable Collective Bargaining Agreement.