Vice President, Regulatory Affairs

Details

Posted : 30-Jan-25

Location : Marlborough, Massachusetts

Type : Full Time

Categories :

Medical Device Quality / Risk Management US Regulatory Affairs Worldwide Regulatory Affairs

Salary Details :

The annualized base salary range for this role is $250,000-$410,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Required Education : 4 Year Degree

Internal Number : 8283

The Vice President of Regulatory Affairs will develop and execute the company’s regulatory strategy to ensure the highest levels of global regulatory compliance. The chosen candidate will have the passion, vision and results-oriented leadership required to build a world-class organization serving a complex, publicly traded global company. Success is defined as being a trusted and influential leader with a highly functioning and results-oriented organization.

This position will define and implement regulatory policies, procedures and systems and will work closely with staff in business units to develop additional policies and procedures that are unique and appropriate to the business unit. He / she will work closely with peers in quality, clinical affairs, research & development, marketing, and operations to ensure all programs advance in a timely and cost-effective manner. Ultimately, this position will represent the company to regulatory bodies and make recommendations to the Executive Committee that ensures the business is acting in the best interest of its key stakeholders (patients, providers, investors, employees).

What You’ll Do

• Overall responsibility for the development and implementation of the vision and strategy as well as budgets for the enterprise regulatory function.
• Ensure products comply with all appropriate regulations.
• In partnership with quality, support proactive relationships with the top management of the FDA and other leading regulatory authorities around the world to build and sustain an outstanding ongoing association.
• The chosen candidate will have the intellectual curiosity to learn new products and technologies and will be a creative problem solver.
• Create and build confidence by establishing the regulatory function as an informed, capable, knowledgeable and accessible resource to staff, management and stakeholders, positioning the company as a preferred source for regulatory expertise.
• Maintain knowledge of the regulatory environment and enable the organization to be subject matter experts and collaborative partners.
• Ensure organization is expert on products and understand the ramifications of any changes to development programs and manufacturing processes.
• Lead a large matrixed staff in regulatory. The chosen candidate will excel at talent management and will proactively work to ensure the organization has the right structure and competencies to meet the current and future needs of the business.
• Ensures compliance with requirements of FDA quality systems, ISO 9001 and EN46001 including maintaining FDA registration and Medical Device Listing for all products.
• Partner cross-functionally with Commercial, Operations, Service, Quality, etc. to support the overall business objectives of Hologic.

What You Bring

Create a Job Alert for Similar Jobs About Hologic We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While we discover and develop groundbreaking products and services that benefit everyone, we are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows and empowers women to experience healthier lives. None of this would be possible without the talent, skills and aspirations of our employees. Their expertise and dedication to developing and sharing more robust, science-based certainty drives our increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families and communities. What powers our growth across Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates us : the exceptional and clinically proven ability of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by always challenging ourselves to improve health through better technology, education and market access. Our... goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses. We work toward this goal every day, always aware that in an increasingly complex and competitive global environment, we must continually earn the trust of our customers and their patients. By focusing on women’s health while still delivering health benefits to everyone, we are setting a new standard of excellence that is strengthened by purpose, driven by passion and brought to life by our promise of more certain early detection and better health outcomes. To view our community guidelines, visit : www.hologic.com / social-media Show more Show less Connections working at Hologic https : / / regulatorycareers.raps.org / jobs / 21027423 / vice-president-regulatory-affairs