Shire Regulatory Global CMC Lead, Devices in Cambridge, Massachusetts

Primary Role:

Under the direction of the Director of Regulatory Affairs, this key role is to function as global lead on device teams. Strategize on deliverables to ensure submission content meets regulatory requirements. Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. Manage medical device Regulatory Affairs activities for developing global CMC medical device and IVD strategies across product life cycles & execution in North America.

  1. Support and development of risk management files, FMEAs, and Human Factors Studies.

  2. Provide collaborative support for execution of global strategies to other regions (EU & International). Manage submissions and interactions with the FDA, Notified Bodies, and Health Canada for device development issues supporting either stand-alone medical devices or combination products. Provide support to other Health Authority (HA) interactions as required.

  3. Provide regulatory guidance and expertise to internal groups such as product life cycle development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.

  4. Manage preparation of US regulatory filings in a timely manner to meet corporate objectives. Responsible for US, EU and OUS Regulatory Affairs for multiple medical device product lines filed as under 510(k), PMA, and EU Technical Files for medical devices, IVDs or combination products.

  5. Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.

Responsibilities:

30%:

Serve as lead regulatory representative on cross-functional product teams, and applying advanced knowledge of regulations and interprets technical regulatory guidelines to ensure that regulatory submissions are in compliance with government regulations.

25%:

Develop global device regulatory strategy for one or more investigational and marketed products

20%:

Lead the preparation and filing of 510k, Technical Files and or CMC sections of regulatory submissions and interactions with regulatory agencies.

15%:

Collaborate with EU & International regulatory colleagues in development of global medical device regulatory strategies.

10%:

Review and approve technical documentation including technology transfer protocols, design validation, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.

Education & Experience Requirements:

• Advanced degree (PhD preferred) in engineering, biochemical engineering or related scientific discipline.

• Masters in Regulatory Affairs strongly preferred.

• Minimum of 10 years of related experience within a pharmaceutical/medical device company, CRO or similar organization and with minimum of 8 years International/Global regulatory experience in medical device and companion diagnostics development and registration activities.

About Shire:

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Equal Employment Opportunity

Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law - Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.