5802- MedTech Compliance Program SME / Quality/GxP Auditor

Description

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise
  
  

MedTech Compliance Program SME Responsibilities:

• Compliance Framework
• Map existing practices and those in process to ensure compliance
• Identify Gaps in established documents &/or framework
• Develop Core SOPs & Policies
• Remediate content Gaps identified within established documents
• Provide Core Gap documents identified (i.e., HCP Engagement; FMV Assessment; Grants, Sponsorships & Donations; Business Needs Forms & Approval Workflows; Tracking logs for engagements and reviews; etc.)
• Incorporate Into Training Program
• Incorporate into Training Program and ensure requirements are defined
• Incorporate into onboarding and periodic compliance training
• Advise
• Attend and provide guidance/recommendations during quarterly Compliance Committee meetings
• Key Deliverables:
• Compliance SOPs, logs, and forms (standardized and approved)
• Annual training records and attestation forms
• Documentation for each HCP interaction, sponsorship or grant
• A simple compliance binder or SharePoint structure
• Readiness to address basic compliance inquiries from internal or external auditors
  

Requirements:

• Demonstrated experience with US Healthcare Compliance subject matter including familiarity with AdvaMed Code, Anti-Kickback Statute (AKS), Sunshine Act, and OIG guidelines
• Experience with commercial, clinical, or regulatory frameworks in medical devices, ideally FDA Class II or III
• Proven ability to create and roll out SOPs, policy documents, and training frameworks
• Comfortable managing activities between EU HQ (e.g., Denmark based operations) and US field or virtual teams
• Strong technical writing ability for SOPs, forms and logs (aligned with regulatory language)
• Ability to prioritize and phase implementation (e.g., start with FMV and grants before less risky policies)
• Capable of developing simple training guides, live/recorded sessions, and tracking acknowledgements
• Ability to maintain accurate recordkeeping, version control and document traceability
• Proficiency in Excel (logs), Word (policy writing) and platforms like DocuSign, LMS or SharePoint (tracking and hosting)
• Bachelor's Degree in life sciences regulatory affairs, business or healthcare compliance
• Certification from HCCA (e.g., CHC), RAPS, or Greenlight Guru's medical device QA/RA programs
• Personal Attributes:
• Resourceful- Knows when to use templates and external guidance instead of over-building
• Practical- Balances compliance with commercial enablement (not overly restrictive)
• Proactive Communicator- Interfaces well across HQ (Denmark), US commercial teams and third party vendors
• Trusted Advisor: Becomes the "go-to" compliance contact for HCP interactions, FMV, grants, etc
  

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

• Verista is an equal opportunity employer.
  
  

National (US) Range

$125,000—$200,000 USD

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement
  
  

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For more information about our company, please visit us at Verista.com