Senior Regulatory CMC Drug-Device Combination Product Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the representative for the Regulatory CMC Device function on cross-functional teams, offering regulatory guidance for combination products and medical devices.

• Draft and coordinate regulatory documentation and submissions, ensuring adherence to relevant regulations.

• Lead or support project assignments that cater to business requirements, including representation of Regulatory CMC in cross-functional initiatives.

• Formulate and implement regulatory strategies for medical devices and combination products, covering new registration submissions and post-approval applications.

• Convey CMC regulatory strategies, risks, and overarching plans to leadership and cross-functional teams effectively.

• Write, review, and authorize CMC submissions and responses to inquiries from Health Authorities, aligning with global regulatory strategies and timelines.

• Collaborate with cross-functional teams to prepare submissions and responses to Health Authority CMC inquiries.

• Keep track of and communicate legislative and regulatory changes in relevant fields.

• Engage in regulatory intelligence efforts and participate in trade organization working groups.

• Develop and improve regulatory processes and procedures continuously.

• Foster strong internal relationships and deliver impactful presentations to internal stakeholders.

⛳️ Requirements

• A minimum of a bachelor's degree (BS) is required.

• At least 5 years of regulatory experience, preferably within the medical device, pharmaceutical, or biotechnology sectors.

• Comprehensive understanding of the regulatory functions within a business context and their interaction with various functional areas.

• Background in Medical Device and/or Combination Product Regulatory Affairs in a similar or entry-level position.

• Knowledge of the application of cGMP for Medical Devices and Combination Products.

• Familiarity with relevant legislation, regulations, guidance, and standards pertaining to medical devices and combination products.

• Excellent analytical skills with a keen attention to detail.

• Preferred: A degree in Life/Health Sciences or Engineering.

🏝️ Benefits

• Regular employees qualify for short-term and long-term incentives, which include cash bonuses and equity incentive opportunities.

• Comprehensive Medical, Dental, Vision, & Life insurance coverage.

• Access to Fitness & Wellness programs, including fitness reimbursement.

• Short- and Long-Term Disability insurance provided.

• A minimum of 15 days of paid vacation annually.

• Additional time off at the end of the year (Dec 26-Dec 31).

• Up to 12 company-paid holidays plus 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan available.

• Tuition reimbursement of up to $10,000 per calendar year.

• Opportunities to engage in Employee Resource Groups.

• Various opportunities for learning, growth, and skill enhancement.